BioSpectrum Asia - November 2016 VK Com Stopthepress

An MM Activ Publication
www.BioSpectrumAsia.com
November 2016
BioSpectrum
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2016| |BioSpectrum
BioSpectrum
October
2016
313
BioEdit
Indias drug policy overhaul
fter relaxing the norms of Foreign Direct

Investment (FDI) in pharma sector in June,
Indian government is now planning to overhaul
the drug policy. The commerce ministry allowed FDI
in existing pharma through the automatic route up to
74%. This development was significant as it removed the
administrative blocks in getting government approvals,
causing delays and encouraging vested interest.
from the National List of Essential Medicines (NLEM),

which has 750 formulations at present. More than
that, two other important suggestions are that the
list of essential drugs for price control should not be
unilaterally decided by the government agency and
prices of the drugs that would remain in the list should not
be imposed but should be decided by negotiations with
industry.
Indian government is now moving further on the same

road and planning to make major changes in the drug
policy itself. The news is encouraging for the domestic industry as well as the foreign companies that are
interested in investing in Indias pharma sector.
These are very sensitive points as they are directly

affect the consumer. The government will have to take
that point into consideration. On the other hand the
industry cannot be happy with the low prices that are
imposed. In 2012 when the upper limit of the prices of
some drugs was restricted the industry had expressed
dissatisfaction claiming that the revenues would go down.
It is high time to overhaul the policy as even the previous policy was implemented as far back as in 2012 and
that too it was mostly continuation of 1994 policy barring
few changes related to pricing. Even the PMO is showing ken interest in overhauling the policy underlines the
urgency of the mater. Different issues reportedly under
consideration in the process of the proposed major overhaul of the policy are being discussed for long time.
The policy is being changed with hope to increase the
investment in the sector and also to reduce regulatory
hurdles and to encourage R&D and innovation. The
intentions are noble as attracting more investment is a
need in view of Chinas increasing market share in the
global pharma industry, resulting in loss of business in
India
While some steps proposed in the policy overhaul
like discontinuing periodic renewal of manufacturing
licenses and making drug related research easy are
good, the most crucial point under consideration is to
review the drug price control regime as it discourages
investment, as suggested by the Niti Aayog. Under this it
is being considered to reduce the number of formulations
4
BioSpectrum
| November 2016
The government controls the prices of essential drugs in

order to provide relief to the common man who cannot
afford high price drugs. In India a large population comes
under this category that needs this relief in price. There
is no doubt that the price control mechanism needs to be
reviewed in order to make the sector investment friendly.
The suggestions by the Niti Aayog to achieve that goal
are in right direction. In such situation, the price control
agency will have to do tight rope balance in inclusion of
maximum number of essential drugs in the NLEM and
to decide the price that will achieve two goals in the one
stroke satisfying the industry by the fixed price and
providing relief to the needy consumer. There lies the
real skill of the government in attracting investments
by decontrolling prices and providing relief to the poor
patients.
Milind Kokje
Chief Editor
milind.kokje@mmactiv.in
|
BioMail
Depression is common!
Care of Mental Health is Need of the

Hour
The interview on mental health scenario of Asia was an

interesting read. It is high time that government gives
preference and allocates fund for mental helath studies
and research just as they give importance to physical
health. After all health is a combination of mental and
physical fitness and well-being
This special issue on mental well-being is an eye-opener.

With increasing suicide cases, it is important that we ward
off stigma and talk openly about mental health as pointed
out by few eminent doctors interviewed by BioSpectrum.
Mr Antony Philip, Australia
Ms Sayali John, India
The magic of herbs!

I am an avid reader of BioSpectrums online portal. The article on Chinese herbs that can cure cancer is a great read.
It is interesting to see how side effects can be minimized and cancer can be cured with Chinese herbs. It is important
that government realizes the potential of botany and allocates more funds for research of these unique herbs.
Mr Phang Weng, Beijing
Vol 11; Issue 11; November 2016

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November 2016
BioSpectrum
COVERStory
INNOVATIONS THAT
REDEFINE HEALTHCARE
Technology has brought a revolution that has redefined the
entire healthcare industry be it connecting to the patients, real
time monitoring, gene editing, drug discovery breakthroughs,
DNA mapping and so on. Breakthrough technologies budding in
the labs are game changers of future.
BIOAnalysis
BIOSpecial
Oncology toDrive
Monoclonal
Antibody
Market
28
VIETNAM
The Next Asian Frontier in
Healthcare
20
BIOTalk
11
HealthcareApps
Phuc Van Pham
Health care in
your Hands!
Professor, Acting Director,

Laboratory of Stem Cell Research
and Application,University of
Science,Vietnam National University
33
23
BioSpectrum
| November 2016
BIOTalk
Dr. Harsh Vardhan
Minister, Science &Technology

and EarthSciences, Govt. of India
08
Prof. Norbert Berend
Head of Respiratory Research,

The George Institute for Global
Health
25
BIOColumn
Clara Heering
Senior VP, Clinical Risk and Data

Management, ICON
18
REGULARS
twitter.com/BioSpectrumMag
BioEdit .............................................................................................. 04
facebook.com/BioSpectrumMagazine
BioMail .............................................................................................. 05
BioNews.......................................................................................... 38
bit.ly/BS-LinkedIn
November 2016
BioSpectrum
BioTalk
Interview
Dr. Harsh Vardhan

Minister, Science & Technology and
Earth Sciences, Govt. of India
ASEAN nations share common vision

for biotech growth
Does the growth of biotech industry in recent
years match up to your forecast? How does
the future of biotech in this country look?
global best practices. Technically, the regulator has been

strengthened and all effort has been made to reduce the
timeline for decision making.
India has today emerged as the fastest growing

large economy in 2015 and looks forward to a
growth of 8-10 percent during the next decade.
The biotechnology industry has grown at a CAGR of 20
percent and in the next decade, we expect this to rise to 30
percent to achieve the ambitious target of USD100 billion
by 2025. The Indian biotech industry is today geared up to
meet the various challenges, and the governments Make
in India and Start-up India missions are contributing
greatly to this. The Make in India mission aims to increase
growth in the manufacturing sector by 12-14 percent and
create 100 million additional jobs by 2022. Biotechnology
is one of the key identified growth sectors.
Three years ago DBT had said that diagnostics

will be the next big focus of DBT. What are
the steps taken in that direction? Which are
the other priority areas?
Critics from the industry feel that the

regulatory regime is a big dampener. Do you
see any change in the scenario over time?
The Department of Biotechnology has promoted this

sector by supporting various programmes, which has
resulted in affordable products of societal and public
health relevance. This area has seen a large number of
successful scientists, entrepreneurs and young start-ups
building their own enterprises. The complete value chain
from product innovation to commercialization has been
facilitated and today we have about 40 medical devices
Q
A
Regulation is an important component contributing

to the biotechnology sector. In the last two years,
special effort has been made to ensure that the regulatory
system is made more transparent and is at par with
BioSpectrum
| November 2016
The medical devices and diagnostics sector is one

of the key sectors identified for the growth of the
biotech industry. The medical technology industry
in India is currently the fourth largest in Asia and is
growing at 10-12 percent annually. My ministry is giving
a special focus to this sector and we hope that India
will be able to capture at least 10 percent of the global
share by 2025.
BioTalk
and diagnostics, some of which have received USFDA
clearances.
What are your views on the governments
Make in India policy? How is the private
sector,
specially
biotech
companies,
responding to this?
As mentioned above, the Make in India policy has

given a special impetus to the growth of the biotech
sector. Because of the focus by the government there
has been a special emphasis on facilitating investment,
fostering innovations ease of doing business. The private
sector has responded very positively. In the recent budget
2016-17, a number of announcements have been made
which have been important to promote this sector, such
as service tax exemption to all BIRAC incubators, special
incentives for indigenous IP protection under patent box,
investment opportunities for startup etc.
Are you satisfied with the outcome on

various projects for boosting R&D and
PPP in biotech industry? How do you view
relevance of bioclusters for the future?
The effort made by the government to promote

R&D and PPP in the biotech industry over the
last few years is paying a rich dividend. The
Department of Biotechnology and its Public Sector
Biotechnology Industry Research Assistance Council
(BIRAC) have provided a special fillip and today we have
more than 500 SMEs, startups and entrepreneurs that
have been supported through more than 600 projects and
government investment of USD 250 million. Nearly 50
affordable products and technologies and more than 100
new intellectual properties have been generated.
I am confident that we will see more industry-academia

partnership and translational research taken forward. We
already have three bioclusters set up in Bangalore, Mohali
and Faridabad and two more are being developed. This
cluster approach is very important to connect the academic
research institutes, industries and entrepreneurs and
provide the critical ecosystem required for translational
research.
Given the deadlock on BT crops in the
country, what according to you are the steps
required to create awareness and connect
with the common man on the issue?
There is no deadlock on biotech crops. There are

many crops in the regulatory pipeline undergoing
different stages of field trials and biosafety tests under
the supervision of the regulatory framework. These crops

are new insect resistant cotton, chickpea, pigeonpea and
brinjal, drought tolerant sugarcane etc.
More than awareness to the common man, the challenge
is to deal with some fringe groups of people who are
giving misinformation to the public. Therefore, a new
biosafety website is being launched for increased access
to information and transparency. Workshops are also
being conducted at state and university level from time
to time for the purpose. Reading material on technology
benefits and risk has been printed in several languages
and distributed.
On the GM crops issue, things are stuck due

to regulation. Coordination between center
and states is lacking too
India has been the pioneer in notifying rules

under the Environmental Protection Act 1986, for
regulation of research, manufacture, use/import/
export and storage of hazardous micro organisms/
genetically engineered organisms or cells. These rules
provided a clear regulatory approval process each at the
level - Institution, State Governments, and at Central
Government - to address scientific risk assessment in
the Ministry of Science and Technology and accord
final approval for environment release in the Ministry
of Environment and Forestry. Interestingly, the rules
also included the constitution of an independent rDNA
Advisory Committee of multidisciplinary experts to advise
on biosafey issues with emerging technologies. Several
guidelines, SOPs for field trials, have been also published
from time to time through a consultative process in
harmony with international best practices.
In the last two years, there have been many reforms in

regulations. Firstly, all the committees are meeting at
regular intervals unlike in the past. A multidisciplinary
risk assessment unit has been established for scrutiny
and evaluation of biosafety data; it supports the statutory
committees such as GEAC and RCGM functioning
under Environmental Protection Act. Risk assessment,
management and communication methodologies and
protocols have been harmonized with best international
practices.
Yes, some state governments are reluctant to provide
permission for conduct of biosafety research field trials
approved by central government. Dialogue and discussion
with states are being taken up along with sharing of
technological and biosafety information. The results of
these efforts have been positive.
November 2016
BioSpectrum
BioTalk
Q
After allowing tests for GM mustard, which

are the other crops considered for GM?
There are many crops in the regulatory pipeline

undergoing different stages of field trials and
biosafety tests under the supervision of the regulatory
framework. These crops are new insect resistant cotton,
chickpea, pigeonpea and brinjal, drought tolerant
sugarcane and salt tolerant rice, herbicide resistant cotton
and corn etc.
What about the arguments about choosing

certain crops of interest for transgenics?
Will it have a demoralizing effect for the
industry in the long run and where does it
lead us?
Make in India campaign has pitched India as a

potential investment destination for genetically
modified (GM) crops. Hybrid seeds, including GM
seeds, represent new business opportunities in India
based on yield improvement. Indian laboratories have
enormous capacity to generate indigenous GM crops
needed for the country.
As a policy, there is no restriction in choosing the crops

and traits. Since the development of GM crops takes a long
time and there is sizable activism to delay commercial use
, it is desirable that investment decisions in using this
technology in a particular crop for a particular purpose
are made appropriately considering other easier and
affordable technological options.
What about the Medtech industry? There was a

proposal to set up a few Medtech parks in the country.
What is the status?
As mentioned above, Medical Technology is

an important sector and the Department of
Biotechnology (DBT) and Biotechnology Industry
Research Assistance Council (BIRAC) have made special
effort to promote it.
Biodesign programme is one of the examples of

inclusive medical technology innovation. This is based
on a novel approach of end-to-end process that begins
with idea generation through clinical immersion up
to commercialization by a multi-disciplinary team
comprising of a physician, engineer, product designer,
and an entrepreneur. The objective of this programme
is to train the next generation of medical technology
innovators who will in turn focus on invention and early
stage development of low cost new medical technologies
for the Indian population. The aim is to develop simple,
10
BioSpectrum
| November 2016
rapid, indigenous, low cost medical devices and implants

by applying four components - affordability, accessibility,
availability and appropriateness.
Under this initiative, several indigenous technologies
have been developed to address unmet medical needs
of India. As an outcome, more than 100 innovators
have been trained. Several national and international
patents have been filed. Various prototypes have been
developed. Some of the Fellows of this programme have
established their start-up companies for further refining,
testing, validating and converting the prototypes into the
products. Thirteen technologies have been licensed and
nine start-up companies launched.
The Department has also established the Healthcare
Technology Innovation Centre (HTIC) at IIT-Madras. This
Centre is delivering innovations and technologies that
are reaching the field through government and industry
partnerships, bringing benefits to lives and our society.
Nearly 100 young entrepreneurs have been supported for
Medtech Innovation and more than 10 Medtech Products
(devices and diagnostics) supported by BIRAC have been
commercialized.
How are you planning to use nanotechnology

to help farmers of India?
Nanotechnology has major advantages for both

healthcare and agriculture. We have supported
key programmes on this sector. A Biotech KISAN
Hub programme is being initiated which will target
all agroclimatic zones and work towards translating
new technologies for the advantage of farmers. Special
programmes on precision agriculture are also being
initiated.
You have announced research scholarships

for researchers from ASEAN countries.
How is the response? How it will help in
strengthening relations with Asian countries
regarding the biotech sector?
For the biotechnology sector, partnership with

developed and developing countries is very
important. ASEAN countries share a common
vision for growth of biotech and India is a key leader
amongst these countries. We hope that through such
scholarships we will be able to encourage scientist-toscientist interaction and also create an environment to
facilitate collaborative research.
BioSpectrum Bureau
|
CoverStory
INNOVATIONS THAT REDEFINE

HEALTHCARE
echnology is power. Technology has brought a

revolution that has redefined the entire healthcare
industry be it connecting to the patients, real time
monitoring, gene editing, drug discovery breakthroughs,
DNA mapping and so on. Breakthrough technologies
budding in the labs are game changers of future. BioSpectrum takes a look at some of the key innovations that have
spurred with the help of dynamic technology and the way
it is designed to transform the healthcare industry.
race to bring the precision medicine to patients on broader scale.

China-based BGI has partnered with Singapore-based
oncology research and diagnostics company Clearbridge
BioMedics (CBB) to bring CTC (circulating tumor cell)
liquid biopsy into the market in Mainland China, Hong
Kong and Macao. The ClearCell technology is a label-free,
automated system able to isolate and enrich intact, viable
rare cells from a patients blood sample.
According to the company, the project focuses on major
types of cancer in China, such as lung, breast, and liver.
The collaboration is to drive clinical adoption of CTC
technology and genomic applications for cancer-related
targeted gene analysis, drug-related gene analysis, single
cell analysis and cancer immunotherapy.
Recently, IBM Watson decided to team up with Quest
Diagnostics in a bid to expand its ongoing cancer
genomic sequencing and precision medicine push. IBM
has been into collaborative arrangements with major
cancer research centers to help oncologists identify better
treatments and clinical trials for their patients specific
cancers.
Precision Medicine
Precision medicine is considered as the future of
treating life threatening diseases such as cancer with more
accuracy and efficacy that has yet not been achieved
through current treatment process. Precision medicine
is a line of treatment where medicine and diagnosis are
tailored to individual patients based on their genetic
profiles. Governments modifying regulations to enhance
investment in precision medicine is an indication to
pharmaceutical companies to elevate resources towards
personalized medicine therapy.
According to Global Market Insight, precision medicine market size is expected to reach USD 87.79
billion by 2023. In 2016, US announced the Precision
Medicine Initiative (PMI), a USD 215 million investment to
accelerate biomedical research and provide clinicians
with new tools to select the therapies that will work best
in individual patients. The PMIs USD 70 million in
funding is slated for the field of precision oncology.
Some of the research companies based in Asia are already
working towards this development and they may lead the
With an idea to enhance its presence in precision

medicine therapy, Singapore has established SingHealth
Duke-NUS Institute of PRecIsion Medicine (PRISM), an
initiative in precision medicine.
Information and communications technology provider
Huawei has teamed up with China-based WuXi AppTec
to support the China Precision Medicine Initiative (China
PMI) through the creation of a precision medicine cloud
platform.
Hong Kong-based Prenetics is a start-up firm that has
developed iGenes test that helps physicians prescribe
medications and dosages to achieve the most effective
results with the least side effects, based on their patients
unique DNA profile. iGenes is a non-invasive buccal
swab test with results available on the Prenetics mobile
application within 48 hours. The company has earned
the interest of investors and has recently received USD
150 million fund towards its personalised and precision
medicine profile.
November 2016
BioSpectrum
11
CoverStory
Boston childrens hospital demonstrated four digital
health tools namely Thermia, RNSafe, Advance seizures
tracking & warninsystems and AudioHub are expected to
fuel the market growth of EHR and consequently smart
healthcare over the forecast period.
Smart Healthcare
Global smart healthcare market is expected to witness
lucrative growth opportunities in the next five years
owing to constant and rapid technological advancements
in the field of healthcare IT such as the development
of electronic health records (EHR), mHealth, and tele
medicine. Furthermore, integration of intelligent
inventory management systems such as RFID KanBan
systems and RFID smart cabinets are expected to save on
cost incurred due to improper handling and expiration
of pharmaceuticals, which is one of the critical success
factors attributing for the growth of smart healthcare
market, highlights a Grand View Research report.
The report mentions that development and emergence of
smart syringes, smart pills, and smart bandages, which
are capable of remotely monitoring patients healing
process, diagnosing gastrointestinal diseases and
minimizing the risk of infection due to multiple usage
of syringes are expected to positively reinforce market
growth during the forecast period. However, budgetary
constraints and poor awareness levels pertaining to the
development of aforementioned products and services
are amongst few restraining factors for smart healthcare
market growth.
Product Insights
In 2014, EHR emerged as one of the highest revenue
generating products segment. Key factors attributing
to its large share include favorable government initiatives such as the emergence of American Recovery and
Reinvestment Act (ARRA) which was intended to
achieve a goal of having all U.S. health care providers
managing clinical information electronically by 2015.
Moreover, technological advancements focusing on next
gen EHR systems such as researchers and clinicians from
12
BioSpectrum
| November 2016
mHealth market is expected to witness a CAGR of over

45 percent by 2020. Key factors attributing to its rapid
growth include their ability to provide insights into
the factors leading to a particular disease, as well as
reduce overall health risks. Rising incidences of chronic
diseases such as cancer, heart ailments and diabetes is a
key contributor to growing demand of mHealth systems.
Moreover, rapid development and increasing purchasing
power has resulted in propagation of smart phones, along
with 3G and 4G networks, which is anticipated to be a
critical success factor for the growth of global mHealth
market and subsequently smart healthcare. 3G and
4G networks enable services such as video calling and
high-speed data transfer which helps in speedy delivery
of telemedicine services.
As patients become increasingly involved in their
individual healthcare, as clinical practice moves from
intuition based decisions to more analytics and data
based approaches, as costs of care to government and
private players spiral upward, healthcare providers
and companies are compelled to revamp strategies and
rethink new methods and models for payment of
healthcare services and products. Moving away from
historically operating in distinct silos, the healthcare
industry is being driven to integrate; with companies
seeking new types of partnerships and collaborations,
as well as dealing with a rising breed of new competitors brought in by the institution of IT based tools and
services, said Ms Rhenu Bhuller, partner and senior vice
president, Healthcare, Frost & Sullivan.
A value-based healthcare approach allows healthcare
systems to effectively track outcomes and actual cost
of care for each patient to understand what is working,
what isnt, and how to minimise waste. For patients, this
means they can expect treatment and disease intervention that is tailored to their needs, introduced at the right
time and focused on improving their quality of life.
3D printing
3D printing is rapidly grabbing interest of the healthcare industry and is set to bring revolution in the
medical device and biotech sector. Stratasys, one of the
leading names in 3D printing segment, remarks that
medical uses for 3D printing, both actual and potential,
can be organized into several broad categories, includ-
CoverStory
ing, tissue and organ fabrication, creation of customized
prosthetics, implants, and anatomical models, and
pharmaceutical research regarding drug dosage forms,
delivery, and discovery. The company informs that the
application of 3D printing in medicine can provide many
benefits, including the customization and personalization
of medical products, drugs, and equipment, cost-effectiveness, increased productivity, the democratization of
design and manufacturing and enhanced collaboration.
Stratasys has set up its first full-colour multi-material
3D printer, J750 3D printer, in Singapore. According to
the company, the new solution breaks restrictive technology barriers, enabling customers for the first time
to mix-and-match full colour gradients alongside an
unprecedented range of materials to achieve one-stop
realism without post-processing.
Traditionally, 3D printing has been used to make dental
implants and custom prosthetics. Stakeholders highlight
that 3D printing has the
potential to produce
bones, ears, exoskeletons, windpipes, jaw
bone, eyeglasses, cell
cultures, stem cells,
blood vessels, vascular
networks, tissues, and
organs, as well as novel
dosage forms and drug
delivery devices.
In April this year, Regenova 3D bioprinter
was installed in Johns
Hopkins
University
School of Medicine to develop scaffold-free multilayer
functional engineered cardiac tissue created from cell
spheroids consisting of iPS cell-derived cardiomyocytes,
endothelial cells, pericytes, and fibroblasts using a 3D
bioprinter.
According to industry estimates, the 3D printer
manufacturing industry observed growth at an
average rate of more than 22 percent annually from 2009
to 2014, totalling USD 1.4 billion. According to IBISWorld
reports, the US market for 3D printer manufacturing will
grow at a CAGR of 15.7 percent from 2014 to 2019.
Linda Tian, analyst for medical devices at Global
Data stresses that in the coming years, medical devices
sector will see more partnerships between small
contract 3D-printing service firms and large orthopaedic companies seeking to explore opportunities in this
revolutionary technology.
This will occur as the clinical community increasingly
acknowledges the efficiencies of a service-based approach
to personalized surgery that combines expertise in
medical imaging, surgical simulation, and 3D printing,
she highlighted.
According to the Singapore Economic Development
Board, 3D bio-printing is rapidly moving towards
commercialization for printing human tissue, organs and
other medical products and the phenomena will prevail
not only in the US but also in Singapore.
Nanotechnology
National Nanotechnology Initiative (NNI) is a US
government research and development initiative
involving 20 departments and independent agencies
working together towards a future in which the ability to
understand and control
matter at the nanoscale
leads to a revolution
in technology and
industry that benefits
society.
Nanotechnology
has
the real potential to
revolutionize a wide
array of medical and
biotechnology
tools
and procedures so that
they are more personalized,
portable,
cheaper, safer, and
easier to administer.
Quantum dots are semiconducting nanocrystals that can enhance biological imaging for medical
diagnostics. When illuminated with ultraviolet light, they
emit a wide spectrum of bright colors that can be used to
locate and identify specific kinds of cells and biological
activities. These crystals offer optical detection up to
1,000 times better than conventional dyes used in many
biological tests, such as MRIs, and render significantly more
information.
Nanotechnology has been used in the early diagnosis
of atherosclerosis, or the buildup of plaque in arteries.
Researchers have developed an imaging technology
to measure the amount of an antibody-nanoparticle
complex that accumulates specifically in plaque. Clinical
scientists are able to monitor the development of plaque
November 2016
BioSpectrum
13
CoverStory
as well as its disappearance following treatment.
Gold nanoparticles can be used to detect early-stage
Alzheimers disease.
Molecular imaging for the early detection where
sensitive
biosensors
constructed
of
nanoscale
components (e.g., nanocantilevers, nanowires, and
nanochannels) can recognize genetic and molecular events
and have reporting capabilities, thereby offering the
potential to detect rare molecular signals associated with
malignancy.
Multifunctional therapeutics where a nanoparticle
serves as a platform to facilitate its specific targeting to cancer cells and delivery of a potent treatment,
minimizing the risk to normal tissues.
Research enablers such as microfluidic chip-based
nanolabs capable of monitoring and manipulating
individual cells and nanoscale probes to track the
movements of cells and individual molecules as they
move about in their environments.
Research is underway to use nanotechnology to spur
the growth of nerve cells, e.g., in damaged spinal cord or
brain cells. In one method, a nanostuctured gel fills the
space between existing cells and encourages new cells to
grow. There is early work on this in the optical nerves of
hamsters. Another method is exploring use of nanofibers
to regenerate damaged spinal nerves in mice. (Abstract
from National Nanotechnology Initiative)
Cancer Science Institute of Singapore (CSI) highlights
that Assistant Professor Edward Chow, Junior Principal
Investigator, NUS, has demonstrated the use of nanotechnology to repurpose existing chemotherapy drugs as
effective agents against chemoresistant cancer stem cells.
Chemoresistance, which is the ability of cancer cells to
escape chemotherapy treatment, is a primary cause of
treatment failure in cancer. Cancer stem cells, a type of
cancer cell which initiates the formation of tumours, are
commonly found to be more resistant to chemotherapy than the rest of the bulk tumour, which can lead to
cancer recurrence following chemotherapy treatment. As
such, there is intense interest in developing new drugs
or treatment strategies that overcome chemoresistance,
particularly in cancer stem cells. The versatility of the
nanodiamond-based drug delivery platform opens up the
possibility of future applications of nanodiamonds such
as the addition of other similar drugs as well as active
targeting components such as antibodies or peptides
against tumour cell surface proteins for targeted drug
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BioSpectrum
| November 2016
release. In addition, the application of a nanodiamonddrug delivery system is not limited to liver cancer. It
offers a promising approach to treating a broad range of
difficult cancers, particularly those driven by chemoresistant cancer stem cells, mentions CSI Singapore.
Robotic surgery
The da Vinci Surgical System is probably the most
fascinating name in robotic surgery. Developed by US
based Intuitive Surgical, the robotic system has claimed
to bring minimally invasive surgery to more than 3
million patients worldwide. The da Vinci System features
a magnified 3D high-definition vision system and tiny
wristed instruments that bend and rotate far greater than
the human hand.
Singapore has installed Da Vinci robotic surgery system
for prostate gland removal, kidney removal and repair
of narrowed ureters. The key benefits of robotic surgery, suggests surgeons, include faster recovery from
smaller incision wounds and less pain, lower blood loss
and reduced need for transfusion, better vision and
tissue dissection from a magnified view and use of special
robotic instruments.
Citing the rising potential and need of robotic surgery,
World Laparoscopy Hospital, has also designed robotic
surgery education program to teach robotic surgery
techniques.
Financial Times report that South Korea is one of the
worlds leading countries for medical robots, with more
than 6,000 operations a year to treat cancer conducted by
robots and is trying to catch up fast with US through its
advanced IT and bio technology.
The global medical robots market is expected to reach
USD11.4 Billion by 2020 from USD4.2 Billion in 2015
at a CAGR of 22.2 percent, according to the report
CoverStory
Medical Robots Market by Product (Robotic systems
(Surgical Robots, Rehabilitation Robots, Hospital
Robots, Assistive Robots, Telemedicine Robots),
Instruments & Accessories) & Application (Orthopedic,
Laparoscopy, Neurology) - Global Forecasts to 2020.
In parallel to Da Vinci, MAKOplasty and Robodoc
are advanced robotic surgery system developed for
clinical use. Expanding its robotic portfolio, US based
Stryker acquired MAKO Surgical for its advancement of
robotic- arm assisted surgery in orthopaedics. MAKOplasty
allows patient-specific 3-D modelling that enables
accurate planning of implant size, orientation and alignment preoperatively. It enables real-time intra-operative adjustments for more correct knee kinematics and
soft-tissue balance prior to resection and has been shown
to provide excellent accuracy and precision with regard
to planned cup position, leg length, and offset. Hong
Kong, Korea and Singapore are already using robots for
surgeries involving orthopaedic, prostate, bladder, kidney,
cervical, rectal and stomach cancers.
Target Drug delivery

Scientists at Nanyang Technological University in
Singapore have invented micro-sized gas bubbles coated
with cancer drug particles and iron oxide nanoparticles,
and then use magnets to direct these bubbles to gather
around a specific tumour. The technology could pave a
new method of delivering cancer drugs deep into tumour
cells.
Drug delivery technology market is expected to reach
USD 1,504.7 billion by 2020 from USD 1,048.1 billion
in 2015, growing at a CAGR of 7.5 percent from 2015 to
2020, according to an analysis. Drug delivery technology market offers a promising approach for the delivery
of various kinds of drugs that have different molecular
formulation. Drug delivery technology is aimed at maximizing the drug delivery at the targeted site so as to
increase the efficiency of drug and proposing improved

patient compliance, highlights Marketsandmarkets.
Global industry analysis report on the advanced
and targeted drug delivery market forecasts a 10.4
percent CAGR and USD319 billion in worth by 2021 from
USD 168 billion.
Frost and Sullivan mentions that the drug delivery space
presents opportunities for technology advancements,
most importantly in the area of scalability. Once drug
delivery
products
start
incorporating
upscale
technologies, manufacturers will naturally focus on
application diversity and seek opportunities to license
out their technologies to various industries such as
medicine, animal health and cosmetics.
Analysis from Frost & Sullivan, Advanced Mechanisms in Drug Delivery finds hydrogels, phospholipids,
microspheres, cyclodextrins and nanotechnology based
formulations are emerging drug delivery mechanisms
that will displace established technologies such as
polymeric micelles, niosomes, phosphorous acids and
starch-based structures. Not only are these new-age
drug delivery mechanisms biodegradable and non-toxic,
they also enhance the bioavailability of drugs, promote
solubility in various environments and ensure targeted
delivery.
The targeted drug delivery mechanism successfully
challenges traditional drug delivery technologies that
have to pass through the gastrointestinal tract to reach
the disease site, writes Karan Verma, Research Analyst,
TechVision. Besides their precision, the emerging targeted drug delivery technologies are noted for their high
lipophilicity, which enhances the entrapment efficiency
of drugs.
While companies can succeed in bringing healthcare
providers on board with the practice of targeted drug
delivery, they will find it more challenging to convince
end users to abandon their trusted traditional solutions.
As things stand, the North American market accounts
for the majority of innovations in the global drug delivery
industry. Unsurprisingly, the majority of drug delivery
technology manufacturers are based in the US, closely
followed by Europe, noted Verma. However, since
Asia-Pacific is the fastest-growing market in terms of the
demand for oral drugs for infectious diseases, it too is
an important region for the drug delivery technology
industry.
Moreover, these new drug delivery technologies will allow
November 2016
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CoverStory
through short messaging service for end consumer to
use and for the manufacturers to incorporate into their
packaging. It works by adding a covert unique identification number (called PIN) on each unit of sale. When
the end consumer buys the product, they can remove the
scratch layer, reveal the PIN, text the PIN to a Sproxil
managed phone number and receive instant response on
whether their product is genuine or not.
A similar technology is developed by Ghana based firm
mPedigree that markets its Goldkeys technology to
manufacturing and marketing companies, government
agencies, and public health organisations. It is a fullspectrum, supply chain visibility, and business process
system used to tracking each pack of product from the
factory, through various warehouses, via retail outlets all
the way to the consumer.
industry players to create a streamlined financial path.

For manufacturers across geographies, partnerships
and alliances will be essential to sustaining costs associated with R&D and the commercialization of products
currently under regulatory review. Venture capital funding, angel investors and series funding also
represent possible sources of financial support for product
development, the analyst concludes.
Counterfeit technology
A report by Visiongain estimated that the world market for pharmaceutical anti-counterfeiting technologies
would be around USD 1.2 billion in 2015 and the market will grow strongly from 2012 to 2022, defeating the
counterfeiting activities.
Dr. Peter Williamson, a pharmaceutical industry
analyst from Visiongain, mentions that, Growth of the
counterfeit technology market will be stimulated by the
introduction of industry-wide standards. Leading
pharma companies are now realising the serious threat of
counterfeit medicines by working closely with anti-counterfeit organisations. Visiongain believes that RFID and
2D barcoding technologies will be key areas of industry
and market growth.
Sproxil, one of the developers of anti-counterfeit
solution, mentions that though some countries are
better financially equipped to utilize new and expensive
anti-counterfeiting technologies, however resource-limited countries require cost-friendly and practical alternatives. Sproxil has developed drug verification technology
16
BioSpectrum
| November 2016
South Australian biotechnology company, GeneWorks,

has developed a DNA barcoding technology for use as a
security and authentication tool. GeneWorks and its cooperation partner DataTraceDNA has developed a multilayer system solution for authentication of drugs that
can be applied on all kinds of pharmaceutical packaging.
While DataTraceDNAs technology is based on covert taggant formulations providing spectral fingerprints readable via electronic handheld devices, GeneWorks technology provides a highly sensitive biological DNA tag.
Indias packaging firm, Bilcare has developed nonClonableID technology that employs unique materials-based
fingerprints that are prohibitively difficult to copy. These
tamper-evident fingerprints are irreproducible and cannot be duplicated. The technology generates unique
fingerprints out of randomly distributed micro and nano
particles that enable an objective and reliable authentication process through hand-held portable readers.
Global firm Axway has developed Track and Trace
technology that provides end-to-end transparency,
supply chain logistics management, and product
authentication services across the supply chains of medical products. Based on an open GS1 standards-based
framework, Track and Trace captures, retrieves, transfers
and manages key product and serialized event data. The
solution centrally manages serial number generation and
allocation and integrates with third-party systems, allowing internal and external trusted parties to access product
identification, location, and event data at any point in the
supply chain.
amrita tejaSvi
|
AD
November 2016
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BioColumn
ADJUSTING
CLINICAL
PRACTICE
GUIDELINES
TO CHANGING
TIMES
Clara Heering
Senior VP, Clinical Risk and Data Management, ICON
timise the efficiency of approaches in

line with this opportunity presented
by ICH GCP, a fairly rigorous review
of processes particularly around
quality is needed.
he International Conference
on Harmonization of Good
Clinical Practice Guidelines,
also known as ICH GCP, must be
adhered to in US, EU and Japan.
However, if an organisation intends
to market its drug or device in these
territories they need to include these
countries/regions in their clinical development plans and consequently
observe the guidelines. The addendum to ICH GCP (R2) is due out
shortly (expected in November 2016)
and organisations need to be aware
of the addendum, how it will impact
the way they work today and the
changes they will need to consider in
a relatively short timeframe.
Why is ICH GCP changing?

The last significant change in the
ICH GCP Guidelines was around 10
years ago, so why the need for change
now? According to the regulators
these changes are being introduced
because of the evolution in technology and risk management processes
and the opportunities these offer to
increase efficiency, by focusing on
relevant activities. This is a positive
move, recognizing that the clinical
trial of a decade ago is not the same
as today. Previously the staffing
structure on trials both at pharma
and investigator sites was simpler,
protocols were more straight-forward and generally the execution of
assessments was more easily monitored with the consistency of staff
and devices. Clinical trials today
Although a draft guideline was issued, the exact details will not be
clear until the final amendment is
published, nor it is it clear if there
will be a period when organisations
will be able to adjust their processes,
systems and most importantly the
behaviours of clinical staff, to meet
the changes required. In order to op18
BioSpectrum
| November 2016
are much more sophisticated. Protocols are more complex and there
are a long list of protocol events,
multiple investigators involved and
potentially a different nurse for each
shift. This can result in protocol assessments being executed differently
from day to day. Since the data needs
to reflect the evolution of the patients
health, not variability because of different approaches in measurement,
this can cause issues in the reliability of the data generated. Due to the
change of size and structure of study
teams, which may include multiple
functions and various vendors, the
sources of emergent study data to be
analysed and assessed has increased.
Clinical monitoring today is more
complex. CRAs need to go to multiple hospital departments in order to
verify procedural compliance. SDV
only verifies errors in transcription
between the source and EDC and not
the possible variations in the execution of the protocol assessments. In
recent years, we have seen some very
exciting technological developments
BioColumn
which support advanced data analytics and the introduction of medical
device and wearables which all bring
advances in execution but challenges
to regulatory requirements.
And yet, the objective of clinical
trials remains the same. We still have
to put the patient at the centre of all
decisions, enhancing patient safety
and being able to confidently rely on
the study results, with a protocol, an
investigator brochure, essential documents, investigational products and
a CRF. The upcoming changes recognize the need for a new approach to
enable consistent detection of errors
in site procedures, and the detection
of trends in possible non-compliance
in protocol assessments at site.
What is changing?
In summary, the addendum focuses
on three key areas: technology and
systems, risk based quality management and monitoring, and oversigh
Technology and systems

To encourage sponsors to adopt
innovative technologies, the ICH GCP
2016 is introducing a new framework
that resolves previous ambiguities
in compliance requirements. This is
a positive development since previous guidance stifled innovation, at
times. There will be an increased requirement to safeguard validity and
integrity of data in systems, in particular, over time and as technologies

evolve. Organisations will need to
manage access and training through
technology, specifically to avoid
improper use of systems and they
will also need to be able to issue certified copies of documents and data.
tive actions and show any deviations

to the plan. This will require a more
adaptive approach than currently
exists in traditional monitoring. In
particular the guidelines mandate
deployment of;
Risk based approach to monitoring
Site and central monitoring based on
risk assessment
The guidelines specifies requirements for the validity, longevity and

fidelity of trial data as sponsors transition from paper systems to digital
records, update their digital systems,
or change from one technology to
another. It also encourages standard
processes to avoid situations where
real-time data aggregation and visualisation may inadvertently reveal
trial outcomes inappropriately early
in the trial process. Finally, to resolve
concerns that digital trial databases
can obscure unauthorised changes
to primary data, the framework expands on the need for control by investigator and institutions of their
generated data and documents.
There will be a need for a process to

be in place to systematically address
significant non-compliance with root
cause analysis and respond with corrective, as well as preventive, action.
Increased oversight
The new guidelines will see the need
for sponsors to have enhanced oversight and for investigators to maintain oversight on tasks they delegate,
including services deployed to third
parties. The investigator and institution will need to maintain control
of data at all times and essential
documents will need to be provided
to sponsor. Sponsors and CROs alike
will need to consider how to enable
effective and efficient support to
sites in order to meet this increased
oversight.
Risk based quality management and

monitoring
There will also be a requirement for

sponsors to maintain oversight of
tasks delegated to CROs. This will
put the onus on CROs to provide
effective systems for transparency
of data and tasks to enable effective
oversight of both their operations
and any third parties that may be
engaged during the trial. Subcontractors appointed by the CRO will
also need to firstly seek the sponsors
approval on delegation.
The changes will impact the focus

on relevant risks to human subject
protection and study data reliability,
with a need to focus on critical data
and processes. It will be necessary to
plan, evaluate and control risk more
diligently and in a way that reporting
of errors can lead to the right correc-
In conclusion, the guidelines are what

we need to adjust our processes to the
changing paradigm of more complex
clinical trials. They herald a more
positive approach to integrating technology and a risk management approach that should see an increase in
quality and efficiency in clinical trials.
November 2016
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19
BioAnalysis
Vietnam-The Next Asian Frontier in

Healthcare
With increasing spending, modernization of medical practices,

improvement of the healthcare system and the development of
technologies, numerous opportunities arise in the Vietnamese
healthcare sector.
ocated in the easternmost part of Southeast

Asia, Vietnam is the worlds 14th-most-populous
country, and the eighth-most-populous Asian
country. Until 1986, Vietnam was under a communist
government and remained impoverished and politically
isolated. In 1986, the government initiated a series of economic and political reforms which began Vietnams path
towards integration into the world economy. By 2000,
it had established diplomatic relations with all nations.
Since 2000, Vietnams economic growth rate has been
among the highest in the world, and, in 2011, it had the
highest Global Growth Generators Index among 11 major
economies. Its successful economic reforms resulted in
its joining the World Trade Organization in 2007.
Though the country has made great strides and seen
economic development in various sectors, Vietnams
healthcare sector faces several challenges. Right from
infectious diseases such as flu to rising rates of chronic
illnesses such as diabetes or cancer, the nation is
grappling with several health issues. Like many devel-
20
BioSpectrum
| November 2016
oping countries, it also has to contend with increasing

resistance to drugs for killer diseases such as tuberculosis
and malaria. Many Vietnamese people still suffer from
the consequences of the Vietnam war, which took place
during the 1960s. The biological weapon, agent orange,
not only killed land crops, but also came into contact with
the human body through contamination of water. It is
not uncommon for Vietnamese women to have miscarriages or children born with disabilities due to this chemical. Reports suggest that the Vietnamese government
currently only invests 0.9 percent of its Gross Domestic Product (GDP) on the healthcare system. This only
serves, roughly, 30 percent of the population. Vietnams
healthcare sector is still under development. But with an
ever-growing aging population, rising economy and increasing international interests, the nation presents investors and foreign healthcare businesses with an exciting
growth opportunity to cash-in on this untapped market.
According to the World Health Organization, there are
only an average of seven to eight healthcare workers and
BioAnalysis
25 hospital beds for every 10,000 Vietnamese citizens.
This is much lower than the global average of 15 healthcare workers and 30 beds per 10,000 people. Nearly 70
percent of Vietnamese stay in rural areas, where it is not
easy to get specialized care in hygienic conditions. The
quality and availability of health services varies dramatically on whether you are in the city or in rural areas.
The majority of hospitals and clinics are located in the
larger cities such as Hanoi, Ho Chi Minh City, and Hai
Phong. However, the good news is that, in comparison
to other countries in the same economic position, Vietnams health care indicators outperform the average,
and they continue to improve at an increasing rate. Progress in controlling vaccine-preventable diseases, such as
measles, diphtheria and tetanus, has been rapid as well;
polio was completely eradicated in 1996. In March, this
year, Vietnam called for drastic measures to foster the
development of private healthcare services in the country
to combat patient overload at public hospitals.
Pharma Market in Vietnam

Vietnam has approximately 300 local drugmakers that
account for more than 85 percent of market volume.
However, imported pharmaceuticals have a total market
share of 60-70 percent. Majority of Vietnams local drugmakers are small-scale and in need of R&D investment
with limited resources. For long, Vietnamese government
has been striving to wean domestic firms off imported
raw materials, however pharma imports to Vietnam are
expected to grow as demand for healthcare outstrips the
rate of progress in homegrown R&D.
Domestic pharmaceutical companies focus mainly on
generic drugs, with very low expenditure on R&D. This
restricts the scope of domestic companies operations,
forcing them to establish themselves either within
Vietnam or through exports. At present, the five leading pharmaceutical companies in Vietnam are Sanofi,
Hau Giang Pharmaceuticals (DHG Pharmaceuticals),
Imexpharm, Traphaco and Domesco.
According to an estimation from the research and
consulting firm Global data, the pharmaceutical market
in Vietnam will expand in value from USD 3.5 billion in
2015 to an estimated USD 6.6 billion by 2020, registering a compound annual growth rate of 13.8 percent. The
report cited increasing elderly population, widespread
preference for imported branded drugs, rising government support for the healthcare sector and the impending gains from the Trans-Pacific Partnership (TPP) as the
main drivers of growth for the Vietnamese pharmaceutical market during the forecast period.
On February 4, 2016, Vietnam signed the Trans paicifc
partnership (TPP), a trade agreement between 12 countries,. On implementation it is estimated that, tariffs on
pharmaceutical imports will fall to 0 percent, and patents
on foreign pharmaceutical companies drugs will be exAn MM Activ Publication
tended from five to 10 years.

Local Vietnamese believe imported drugs are much more
effective and tend to prefer them over generics. Soaring
growth, slashed pharma import tariffs and patient preference for foreign drugs makes Vietnam a strong contender
among the 12 Asia-Pacific countries who signed the Trans
Pacific Partnership (TPP).
However, experts opine that the deal will deter the growth
of local players. The extension of intellectual property
rights for overseas pharma, from five to ten years, might
delay domestic firms from producing new treatments.
As already majority of Vietnams drugmakers manufacture generics, this will present a major challenge to local
industry.
Due to tough competition many local drugmakers are in
the process of upgrading their existing facilities to meet
international standards. For example, DHG Pharmaceutical has built a new manufacturing facility, while Hanoi
Pharma has constructed a new production line for plastic
injection tubes.
Government initiatives to promote Biotechnology

Conscious of the huge challenges the country is currently
facing, the Vietnamese government has set up a comprehensive roadmap to 2020 to improve all major aspects
of the country healthcare system. To prevent overcrowding in public hospitals, the government is aiming to an
increase bed capacity by 20 percent. The government
has introduced many master plans since 2012 addressing
key areas such as public health insurance, hospital services or access to drugs. Parallel to this master plan, the
Ministry of Health has also published the national health
insurance plan targeting a national coverage of nearly
80 percent population by 2020 (vs. less than 60 percent
coverage today). To achieve this ambitious target
Vietnam needs to upgrade and modernize the healthcare
system and improve the infrastructure and facilities in its
public hospitals.
The establishment of the ASEAN Economic Community
(AEC) in 2015 will help in increasing labor movement
across the ASEAN countries as it allows doctors and
dentists to work across ASEAN countries. This will help
with Vietnams problem of finding qualified healthcare
workers to staff needed medical centers. Highly-skilled
workers moving between ASEAN markets will also help
with research and development and improve the quality
of Vietnams medical services.
In its bid to promote research and development and
invention of new medical interventions, the government
has identified biotechnology as one of the national development priorities and the sector continues to receive
increasing budget allocations as well as seen interesting investments from the private sector. Every year,
the countrys Ministry of Science and Technology funds
November 2016
BioSpectrum
21
BioAnalysis
fuel socio-economic growth in such localities, improve
the competitiveness of the national economy and raise
hi-tech content in locally-made products and boost
scientific and technological development in the country.
Meanwhile, the Government has plans to further develop
national hi-tech parks such as Hoa Lac Hi-Tech Park in
Hanoi City, Saigon Hi-Tech Park in HCMC and Danang
Hi-Tech Park. The Government has also decided to build
other projects such as Hanoi biology hi-tech park, Dong
Nai high biotechnology park and Ascendas-Protrade
hi-tech park in Binh Duong Province.
With a view to increase the workforce and develop skilled
labor in biotech sector the countrys Ho Chi Minh City
administration has plans to send a number of trainees overseas for training in masters- and PhD-level
biotechnology under a plan to improve the caliber and
knowledge of local personnel in 2016.
Make in Vietnam
nearly 20-50 biotechnology projects. With many unmet

medical needs, the country represents a potentially large
healthcare and device market.
Vietnams biotechnology development began in the
mid-1990s, when researchers at the University of
Medicine and Pharmacy in Ho Chi Minh City conducted a series of polymerase chain reaction (PCR) experiments. Now, the country has many new biotechnology
research centers that harness technology to tackle cancer,
diabetes, and antibiotic-resistant infections. Few institutions, for example, the Institute of Biotechnology and the
Military Medical University in Hanoi are well equipped
with microarrays, high-resolution electron microscopes
and mass spectrometers. These centers are working on
proteomic and genomic research to develop treatments
for unmet diseases such as diabetes, high blood pressure
and cancer.
In June last year, the Prime Minister approved a master
zoning plan for hi-tech parks in the country by 2020 with
a vision to 2030. Accordingly, provinces and cities will
develop a number of hi-tech parks using their budgets
and other resources.
The plan aims at attracting investments in hi-tech projects and bolstering the sectors development.
Dong Nais hi-biotechnology park is among the hi-tech
projects approved by the Government. A hi-biotechnology park in Hanoi and the Ascendas-Protrade hi-tech
park in the southern province of Binh Duong Province
have also got approval. The new high-tech parks aim to
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BioSpectrum
| November 2016
With rising consumer class, many healthcare challenges,

Vietnam offers several exciting opportunities in healthcare sector. The government is making it easier for foreign investors to participate in the growing healthcare
industry. In 2014 and 2015, the government issued
decrees to help develop the health care industry and to
expedite the cooperation between public and private providers.
During his recent visit to India, Vietnamese ambassador
Ton Sinh Thanh as a part of the Make in Vietnam initiative has urged Indian pharmaceutical companies to set
up units in that country. Thanh said that pharmaceuticals
are one of the major items that Vietnam imports from India. Thus, Indian pharmaceutical companies should set
up base there as a part of Make in Vietnam initiative.
Vietnams desire to modernize the healthcare system
should generate plenty of business opportunities in the
upcoming years. In addition to new hospitals, opportunities also exist in relation to healthcare products and
more specifically medical equipment and drugs. The US
Commercial Service has estimated in a public report published in June 2014 that the medical equipment market
would be amongst the fast growing in Vietnam for U.S
based manufacturers given the urgent need to replace old
medical devices in hospitals. Market research specialists
like BMI also predict double-digit growth in the next few
years for both the medical equipment and drug markets.
In a nutshell, the continuous increase in healthcare
spending combined with the necessary modernization
of the Vietnamese healthcare system and ambitious national development plans should continue to drive strong
growth in the healthcare market over the coming years.
aiShwarya venkateSh
|
BioTalk
Interview
Phuc Van Pham
Professor, Acting Director,

Laboratory of Stem Cell Research and
Application, University of Science,
Vietnam National University
Govt to build innovative

environ for research
Q
Please explain the current scenario of

biotechnology and stem cell research in
Vietnam
At present, the biotechnology in Vietnam focuses

on translational studies to develop new medical
interventions. Few sectors that are prominent are:
- Medical biotechnology: included stem cells, that

research to produce and commercialize some antibodies
used as drugs or/and diagnosis, cytokines, especially cell
therapy.
- Agriculture biotechnology: focus some modern
techniques to safe production, animal breeding.
Particularly, stem cell research and applications are
considered as prior subjects. Some universities and hospitals use modern techniques in cell and stem cell research.
Few universities also undertake researches involving
screening of natural products to develop the supplement
and/or functional foods.
Please outline the initiatives and efforts of

the Vietnamese government to nurture the
biotech sector?
There are some programs that government has

initiated to nurture the biotech sector- National
program of technology innovation - 2020. Under
this program, the government has specific plans to help
companies involved in biotechnology in food, medicine,
pharmacy. This program also undertakes trainings to

develop skilled workforce. Another initiative from government is the- Fostering innovation through Research,
Science, and Technology (FIRST) program. Apart from
this the government also has some innovation partnership
program with some countries as Finland (IPP) National
Foundation for Science and Technology Development
(Nafosted) is yet another program devised by the government. Through this program, the government aims to
build a durable, innovative and conducive environment
for research at universities and institutes, improve the research capacity of young scientists and establish research
centers that meet international standards, enhance the
quality of scientific research and increase the number of
Vietnamese research published in ISI-covered journals.
The program also aims to encourage international cooperation for Vietnamese scientists to approach international research knowledge and to attract external funding to Vietnams scientific projects and promote research
efforts in enterprises, with focus on core technologies
development contributing to national economic growth
and competitiveness. With these plans, it is expected that
by 2020, Vietnam will have three national centers of
biotech at Nothern, South and Middle; and other 10
key national laboratories of biotechnology. National
laboratory of stem cells is one of these 10 labs.
Please outline government support for research in terms of funding.
November 2016
BioSpectrum
23
BioTalk
Every year, the countrys Ministry of Science and
Technology funds nearly 20-50 biotechnology
projects. Most of these projects involve gene techniques in disease diagnosis and recombinant protein
technologies to product protein and recombinant vaccine
to diagnose and treat diseases. Another major area that
attracts funding is cell technology and stem cell therapy
for treatment in humans.
What are the current challenges faced by

Vietnams biotech industry?
There are many challenges. Though the government

is providing funding and encouraging research
Vietnam has not yet identified its strengths in
biotechnology. There is also very high competition.
Vietnam companies have small scale production, slow
technological innovation application; and there is a need
for skilled workforce and good infrastructure. There is
also a serious shortage of biotech experts or engineers,
although some universities have started with some
training biotech program, the quality of program is low.
What is the government doing to combat

these challenges?
To combat these challenges, the government has

set up a biotech national program that aims to discover the strengths of Vietnams biotech industry.
The government then plans to fund these strengths to
24
BioSpectrum
| November 2016
foster development. To encourage homegrown R&D the

government is also supporting some companies to
apply the new technologies that can help reduce price and
increase the quality.
The government is also aiming at building a skilled workforce by increasing the quality of training and education
of biotechnology. National scholarships are also provided
for students to study at US, Japan, or EU.
How do You see Vietnams biotech sector

five years from now?
Biotech industry will develop in Vietnam but not

significantly in the next five years. Two major areas
where we hope to see significant improvement is
stem cell therapy/technology, vaccines and recombinant
proteins research.
In your opinion what are the major urgent

changes needed in the industry?
In my observation, the biotech industry of Vietnam

is developing at a slow pace. Motivation, encouragement and funding the right studies is the key to
foster the sector. Vietnam needs to devise a strategy plan
and identify the strengths and weakness of the sector and
work accordingly. Also, there is a need to commercialize research and translate it into end products. Currently
the government focuses on research but not much of it
actually goes into production.
BioTalk
Interview
Prof. Norbert Berend
Head of Respiratory Research,

The George Institute for Global Health
GlaxoSmithKline and biopharmaceutical company, Innoviva, have concluded Salford

Lung Study (SLS), a Phase IIIb multi-centre, open label randomised controlled trial
designed to evaluate the effectiveness and safety of GSKs drug, Relvar Ellipta, in
patients with chronic obstructive pulmonary disease (COPD), compared with their
usual care administered in an everyday clinical practice setting.
Prof. Norbert Berend, Head of Respiratory Research, The George Institute for Global
Health and former President of the Thoracic Society of Australia and New Zealand
and the Asian Pacific Society of Respirology, has a strong research background
in asthma and COPD. In an interview with BioSpectrum, he shares his views on
the prevalence of COPD in Asia and the effective ways to control and manage the
disease.
sia is still lacking in COPD management.

There is little awareness among patients
to effectively manage the disease or
even consult specialists. How do you think the
burden of COPD can be handled in Asia in such a
scenario?
infections and pulmonary rehabilitation which is virtually non-existent in many countries. Given the substantial
socio-economic burden of the disease, it is also important
for healthcare providers to make advanced treatment
options widely available and accessible for patients in
both private and public health-care systems.
Despite many risk factors like high smoking rates,

exposure to biomass smoke and air pollution, the prevalence of COPD in Asia is similar to Western countries.
However, the effectiveness of policies to reduce these
risks is in question. What is required is a greater effort for
primary prevention and then allocation of appropriate
resources to treat the condition with both pharmacological and non-pharmacological interventions. The latter
include vaccination against influenza and pneumococcal
According to a study done in 2010 by the Canadian Lung Association along with medical experts
from Canadian Thoracic Society, titled Awareness of risk factors among persons at risk for lung
cancer, chronic obstructive pulmonary disease
and sleep apnea: A Canadian population-based
study, the awareness level of COPD in western
countries is as low as 17 percent and far worse in
Asia. What role can pharmaceutical companies
November 2016
BioSpectrum
25
BioTalk
play to increase the awareness of the disease?
Pharmaceutical companies should team with national
and international respiratory societies to develop patient
education platforms. In addition, there should be more
effective patient advocacy groups which can, again, team
with pharmaceutical companies to develop better patient
education programs and lobby governments for greater
allocation of the resources to treat this condition.
Kindly shed light on the SLS study. What
difference can Relvar Ellipta make in the existing
COPD management process?
In essence, the study shoes that Relvar Ellipta, used in
patients diagnosed to have COPD in general practice,
with a lot of symptoms and exacerbations can deliver an
8.4 percent reduction in exacerbations compared with
patients in the usual care group, with only 7 patients
needed to be treated to save one exacerbation.
The Salford Lung Study (SLS) is an open label randomised
controlled trial (RCT), with very broad inclusion criteria,
that aims to guide COPD treatment choices by generating
unique effectiveness and safety data in a patient population intended to represent that seen in everyday clinical
practice.
The study is sponsored by GSK, and designed and made
operational in collaboration with multiple stakeholders
- North West e-Health, The University of Manchester,
NHS Salford and healthcare providers in Salford including GPs, nurses and community pharmacists.
It is the first pragmatic, randomised controlled trial to
be initiated prior to the medicine being licensed, as an
important complement to RCTs in order to establish the
value of a medication in an everyday clinical setting and
will offer a different type of evidence of the risk/benefit
profile of FF/VI in a wider COPD population.
The study compares the effectiveness and safety of Relvar Ellipta (FF/VI) versus usual care, using electronic
medical record (EMR) system, which links GP practices
and hospitals, enabling data on study endpoints and
patient safety to be collected continuously and remotely with minimal intervention or intrusion into patients
everyday lives. It has provided important information for
clinicians, healthcare providers, payers and patients on
the effectiveness and the true value of the medicine.
The study results show Relvar was superior to other
COPD treatments, defined as usual care, achieving a statistically significant reduction of 8.41 percent in the rate
26
BioSpectrum
| November 2016
of moderate or severe exacerbations (p=0.025). This

means that FF/VI can help prevent 1 moderate/severe
exacerbation for every 7 patients treated over 12 months
with usual care. GSK is continuing to analyse data from
the study and believe that the unique data generated from
this study will provide a wealth of information about
COPD patients and disease management that we believe
will help healthcare decision makers.
Relvar Ellipta (FF/VI) is the only inhaled corticosteroid/
long-acting beta agonist (ICS/LABA) which provides
24hr continuous efficacy in a once daily dose, combined
with a device with higher patient preference and fewer
critical errors compared with other ICS/LABAs. It
provides physicians with an advanced treatment option
delivered via the Ellipta inhaler to meet the needs of
patients with asthma and COPD.
What are the effective ways of managing COPD at
an early level? How can this be implemented in
Asia given the wide demographics?
The essential goal of effective COPD management is
to improve a patients quality of life by preserving an
optimal lung function, improving their symptoms, and
treating and preventing the recurrence of exacerbations
to reduce mortality. In addition health education and
adjunct therapy can also play an important role in
improving patients ability to cope with illness, including
support for smoking cessation.
The single most important intervention is smoking
cessation as part of both primary and secondary prevention. It is the only intervention shown to reduce the rate
of decline of lung function.
In addition, patients present with symptoms late in
the course of the disease. In many cases 50 percent of
lung function has already been lost when patients first
present with disease symptoms. Symptoms are often
sub-optimally treated and ongoing symptoms are associated with exacerbations and hospitalisations. Every effort
should be made to achieve best possible lung function
using combination of long-acting bronchodilators. The
recognition that a patient exacerbates frequently should
be a taken as a signal for rapid decline of lung function
and high mortality and needs to be treated with medicines that have been shown to be effective in reducing
exacerbations. When patients have a lot of symptoms as
well as frequent exacerbations, inhaled corticosteroids
in addition to combination bronchodilators i.e. triple
therapy should be considered.
What should be the priority of pharmaceutical
BioTalk
companies and clinicians when it comes to managing the right intervention for COPD patients?
COPD patients have disabling symptoms and exacerbations which result in a poor quality of life. Diagnosing
the features of COPD which contribute most to the poor
quality of life enables clinicians to select the most
appropriate treatment for the patient.
inhaled corticosteroids that are able to be used once daily

with easy to use inhalers. Hence, clinicians and pharma
companies should ensure that these advanced treatment
options are easily available in both private and public
health care systems to truly meet patients needs. Clinicians should also not neglect non-pharmacological treatment like flu and pneumococcal vaccination and pulmonary rehabilitation or at least regular exercise.
We are fortunate that in contrast to the situation in the

past we now have highly effective bronchodilators and
amrita tejaSvi
November 2016
BioSpectrum
27
BioSpecial
Oncology to Drive Monoclonal

Antibody Market
sia-Pacific
Monoclonal
Antibodies Market is valued
at USD 4.32 billion in 2015
and is forecasted to be a USD 8.14 billion market by 2020, market report
According to Market Data Forecast,
Asia-Pacific monoclonal antibodies market is valued at USD 4.32
billion in 2015 and is forecasted to be a
USD 8.14 billion market by 2020
with a tremendous growth rate of 13.5
percent. Cancer is the leading cause
of death across the globe currently.
The adverse side effects of drugs
and chemotherapy used as a treatment to cure cancer has made the
pharmaceutical
companies to concentrate on monoclonal
antibodies,
the
report
mentions. Over the years, the
demand for production of antibodies is
28
BioSpectrum
| November 2016
likely to increase owing to the rising

demand for monoclonal antibodies
globally and rising R&D expenditure
of pharmaceutical and biotechnology
companies. Moreover, emerging
markets of India and China, rising
demand for protein therapeutics,
and increasing risk of pandemics
and infectious diseases are likely to
increase the demand for equipment
and consumables used in antibody
production, according to a report by
Markets and Markets.
Polyclonal), by Technology (Hybridoma), by End-User (Biopharmaceutical Companies, Diagnostic Labs,

Research Institutes) - Analysis &
Global Forecast to 2019, published by
Markets and Markets. Some of the
major players in the global antibody production market are GE
Healthcare, Thermo Fisher Scientific, Sigma-Aldrich, Sartorius, Merck
Millipore, Abcam, Amgen, Sanofi,
Rockland Immunochemicals and
Roche Applied Science.
The global antibody production market is expected to reach USD 2.572

billion by 2019 from USD 1.425 billion
in 2014, growing at the rate of 12.5
percent, according to a new market
research report Antibody Production Market by Product (Equipment,
Consumables), by Type (Monoclonal,
Recent Developments
Fortis Therapeutics, an immuno-oncology biotech company, has raised

USD 18 million investment led by
Avalon Ventures. Fortis is focused on
developing new antibody drug conjugate therapies for late-stage metastat-
BioSpecial
ic castrate-resistant prostate cancer
and multiple myeloma
Bin Liu, a professor in the Department of Anesthesia at UC San
Francisco on whose technology Fortis
Therapeutics is founded, has identified a novel and unique target for
an antibody drug conjugate therapy
that could help patients with prostate
cancer or multiple myeloma where
other treatments have failed,
announced Jay Lichter, President
and CEO, Fortis Therapeutics and
COI Pharmaceuticals, Managing
Director of Avalon Ventures.
Fortis Therapeutics is developing a
new antibody drug conjugate (ADC)
therapies that target a receptor that is
over-expressed in late-stage prostate
cancer including both the adenocarcinoma and neuroendocrine types.
Furthermore, the genes encoding
the target receptor are part of the
chromosome amplification seen in a
large number of multiple myeloma
patients with poor prognosis. Different from the majority of other ADC
targets, which are predominately
lineage markers, the target Fortis is
pursuing is part of the tumor immune
defense shield and is highly expressed
throughout tumor development. The
target is further up-regulated following standard of care treatment with
abiraterone or enzalutamide, which
is used in combination with prednisone to treat metastatic castration-resistant prostate cancer, the company
states.
China
based
biopharmaceutical
company, TOT BIOPHARM, is developing second phase monoclonal
antibody drug production facility at
Suzhou Industrial Park. The company is engaged in discovery and
development of innovative anticancer drugs and therapies. The
production unit will be put into trial
production in 2018, followed by
formally rolling out commercial
production in 2019. Once construc-
also plan to initiate a Phase 1 study

of CBT-501, an anti PD-1 monoclonal
antibody, in south-east Asia in 2017.
An Investigational Drug Application
(IND) has been filed and CBT-501 is
also awaiting the start of a Phase 1
trial in China.
tion is completed, the facility will

have five production lines with a
cell culture capacity of 2,000L and a
production capacity of 10,000L of
monoclonal antibody drugs.
Singapore based ASLAN Pharmaceuticals has recently entered into a
licensing and research collaboration
agreement with Nanyang Technological University, Singapore for the
development of Modybodies, a novel
type of stabilised heavy chain monoclonal antibody (mAb) fragments.
According to the partnership terms,
ASLAN will collaborate with NTU
on the development of Modybodies against three targets of ASLANs
choice and has an exclusive option,
under pre-negotiated terms, to obtain
global rights to develop and commercialise Modybodies. ASLAN expects
the first Modybody from the collaboration to enter clinical development
in 2018. The technology originated
from a laboratory at NTUs School
of Biological Sciences headed by
Professor Pr Nordlund, a worldleading structural biologist who established the Structural Genomics
Consortium laboratory at Karolinska
Institutet, Sweden.
Bispecific antibodies:
A Transparency Market Research Report
Bispecific antibodies are recognized
as artificial protein where two or
more antigen recognizing elements
are combining together to form a
single construct. Bispecific antibodies are able to bind into two or more
targets at a time. Moreover, these
antibodies might bridge two targets together and are able to present
high chances of gaining therapeutic
effects (bring cancer cell within striking
distance). The various formats of
bispecific antibodies include quadromas, chemical heteroconjugates,
bispecific antibodies with special
heterodimeriza-tion domains and
bispecific antibodies of minimal size.
Bispecific antibodies are primarily
utilized for the treatment of cancer
and are emerging as a novel technology for dual targeting strategies
within one molecule for cancer treatment. Bispecific antibodies improve
and ensure the following factors in a
cancer targeting agent: increase binding ability, improve selectivity and efficacy. It has observed that bispecific
antibodies provide improved efficacy
for cancer treatment as compared
with combination therapy of other
two antibodies. Recombinant DNA
technology is identified as the backbone of rapid expansion of bispecific
antibody formats.
CBT Pharmaceuticals, a life science

start-up company focused on developing innovative oncology therapeutics, has recently raised USD 9.75
million investment led by OrbiMed
Asia. The financing allows us to
advance two of our four development programs into human clinical
trials, commented Dr Sanjeev Redkar, President and CEO, CBT. CBT101, a highly specific inhibitor of the
c-MET receptor, has shown robust
activity in patient-derived xenograft
(PDX) models with a wide safety
margin. CBT-101 is currently in a
Phase 1 trial in China, and we plan to
initiate a Phase 1 study in the United
States in early 2017 to evaluate the
safety, tolerability and preliminary
efficacy in cancer patients with cMET dysregulated malignancies. We
Bispecific antibodies are evolving

a the most preferred and efficient
method of treatment for various
cancer such as breast, lung, prostate
and colon cancer. With rising prevalence of different types of cancer
(lung cancer, breast cancer and cer|
November 2016
BioSpectrum
29
BioSpecial
vical cancer) the global market for bispecific antibodies
treatment is significantly increasing. The World Health
Organization (WHO) published in 2014, that worldwide 8.2 million people died of cancer in 2012. Likewise, American Cancer Society (ACS) published that,
around 300,000 men and 276,000 women died due to
cancer in 2012 in the U.S. Moreover, it is observed that
of every six U.S. men have received a diagnosis test for
prostate cancer at some point in their lives stated by
California Journal of Clinical Cancer (CJCC). However, technical complexity associated with the treatment
procedure (detection) of bispecific antibodies would
hinder the global market demand of bispecific antibodies
treatment during the study period.
North America and Europe were observed to be the
largest bispecific antibodies treatment market due to major market players are based in these regions. Moreover, it
has observed that the highest numbers of various cancers
(lung cancer, prostate cancer, breast cancer and cervical
cancer) diagnosis cases are recorded from North America and
Europe every year. In addition, favorable initiatives taken
by the federal government also would be accounted for the
market growth of bispecific antibodies treatment in North
American and European regions. Similarly, Asia-Pacific is
considered as an untapped market in bispecific antibodies treatment due to lack of proper healthcare facilities in
some Asian countries. Asian market growth will be fuelled
by the presence of untapped opportunities due to extensive
increase in the healthcare infrastructure (healthcare cost,
healthcare facility and health care budget). Similarly, AsiaPacific is considered as an emerging market in bispecific
antibodies treatment due to growing market penetration in
this region. The rest of the world (RoW) holds fourth position in the global bispecific antibodies treatment market
due to poor economic and health condition in most of the
African countries. It has also observed that bispecific antibodies market growth in RoW will be fuelled primarily by
extensive increase in healthcare infrastructure in Brazil and
Mexico.
Some of the major players operating in the bispecific
antibodies treatment market includes AbbVie, Celgene,
Ganymed Pharmaceuticals, Janssen Biotech, OncoMed
Pharmaceuticals, Paktis Antibody Services, Fabion
Pharmaceuticals among others.
https://twitter.com/BioSpectrumMag
Source: Transparency Market search Report
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www.biospectrumIndia.com
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Debate
still rages on GM crops
31
HealthcareApps
Health in your Hands!

Increasing smart phone penetration,
growing popularity of healthcare apps
and the need for connected devices to
improve healthcare systems clearly state
that m-health has a promising future
in Asia
less expensive, more preventative,

and in many cases downright better. It is estimated that there are now
approximately 165,000 health-related apps which run on one or other of
the two main smart phone operating
systems, Apples iOS and Googles
Android. PwC, a consulting firm,
forecasts that by 2017 such apps will
have been downloaded 1.7 billion
times. Increased access to smartphones and the internet suggest that
the mobile health market will enjoy
a compound annual growth rate of
more than 30 percent during the next
four years. Allied Market Research
values the global mobile health
market at nearly USD 11 billion. With
the number of mobile phone users
in the Asia Pacific expected to grow
from 2.5 billion to more than three
billion in the coming years, mobile
health technologies will become even
more accessible. By taking advantage of these trends, medical device
companies can tap into a growing
market that is demanding better,
cheaper healthcare services.
magine being housebound for two

to three days due to terrible snow
or a bad storm! Your baby has
severe fever and all roads are blocked.
What a bad situation to be in!
However with a smartphone in your
hand it is not all that bad. With scores
of healthcare apps at your disposal
you can see a doctor immediately
from the comforts of your home and
in some cases even get a medicine
prescribed. In the not-so-distant
past, patients had only one source
for healthcare expertise their
personal physicians. They relied
on doctors to monitor their symptoms, track changes in their health,
manage their diseases and personalize their care. But in recent years,
mobile technology and the Internet
of Things (IoT) has changed it all.
Today, smartphones are affordable,
are of a very high quality, and every other person has a smartphone.
Entrepreneurs,
companies,
and
organizations across Asia are cashing-in on this huge penetration of
smart phones with novel healthcare
apps that promise to resolve many
healthcare issues and speed improvements to healthcare delivery.
Dr Jacques Durand, founder of Doctor Gratis and Medical Director/

International Health Consultant
Medika Consulting
explained,
Technological innovation is the key
Healthcare apps are dramatically

making healthcare more convenient,
32
BioSpectrum
| November 2016
Dr Jacques Durand
to many of healthcares current and
growing woes--including costs, an
expanding elderly population and
inefficiencies within the healthcare system. From the physician
side, a better collaboration between
family doctors and specialists, using
digital technology to keep records
and share information, and giving
greater priority will increase productivity. All healthcare professionals
will use digital tools for develop real
time care team services for delivering
better medical outcomes.
Doctor Gratis is an app for people in
Indonesia to get free live consultation
with a doctor. There are two teams
who helped produce the app. The first
is Warung Kreasi which develops the
app. Second is Medika Consulting
HealthcareApps
which takes care of the chat function
and social media operations. Doctor
Gratis is also a partner of Singaporebased medical social platform Blabla
Doctor.
A huge increase in the usage of smartphones, particularly in India and
China, has empowered the middle
class to access such apps to solve
some parts of the healthcare problem.
As they use apps more often, startups
are able to generate more data on
patients, which in turn helps them
design better products. Going
forward, healthcare startups that
generate and analyse big data will
be attractive opportunities for investors. Data is changing healthcare, by
improving clinical intelligence by co
mbing through vast amounts of data.
With users becoming more conscious
of health, and earn higher salaries,
both health and wellness app makers
have a huge market to tap.
Smartphones are one of the
recent technology developments
that will have the strongest impact
in healthcare, because within this
small device, the range of possible
functions becomes almost limitless,
highlighted Eric Stephen, Technical
Advisor, FHI360, Remember that
a smartphone is a fairly powerful,
ultra-portable computer. So beyond
collecting health data, photos, or
GPS coordinates, it can also perform
calculations, store and retrieve data
from the internet, and display clear
interfaces for users. Further, once
you realize that additional small
devices for medical measurements
can be attached to a smartphone, its
hard to imagine limits to the possibilities in fighting HIV, TB, malaria,
and any number of other epidemics.
FHI 360 is a nonprofit human
development organization dedicated to improving lives in lasting
ways by advancing integrated, locally driven solutions. For more than
30 years, FHI 360 has been dedi-
cated to crafting unique technology

based solutions that respond to the
multifaceted nature of HIV and AIDS.
In Asia right now, FHI 360 is proudly
implementing the LINKAGES project which conducts a range of HIV
prevention activities to reduce HIV
transmission among key populations.
LINKAGES Thailand is pioneering a
new model for increasing uptake of
HIV testing and counseling. In partnership with local community-based
organizations the project has introduced an enhanced peer mobilizer
model (EPM) to increase HIV testing
and counseling, and improve enrollment and retention of those who test
positive in care.
the region even today many treatable

infections claim thousands of lives.
A number of advantages are crucial
for rural medicine, added Stephen.
First, the devices are extremely
portable, which means that a health
worker can take them on rounds to
remote villages, just as easily as they
can be used in larger health facilities.
More fundamentally, the price of a
smartphone is far below that of laptops or other equipment. Our projects tend to use smartphones running
the Android operating system, which
can be purchased for USD 100-120,
and sometimes below USD 100. That
is not cheap in a low-resource country, but it leaves open more doors
than approaches that required a
laptop
computer.
Furthermore,
smartphones allow easy-to-use interfaces that make it possible for applications to actually guide the steps to be
taken by healthcare workers with lower
levels of training.
M-health- The new

healthcare revolution
In Asia there is serious shortage of
medical professionals and hence
millions of Asians today lack access
to affordable, quality healthcare.
The regions per capita spending on
healthcare averages is lesser than
recommendation and this deters
much-needed investment in new
hospitals, equipment, and the
information technologies that power
modern healthcare systems management. It also contributes to the
regions shortage of skilled healthcare
professionals. In many rural areas of
Along with improving general wellness, these apps play a major role
in allowing greater patient engagement which means most individuals
are now focused on improving their
health and are better aware of the
complications of the disease. Many
diseases also have support groups
and forums where patients can
|
November 2016
BioSpectrum
33
HealthcareApps
So far, big drugmakers have been
slow to join the m-health revolution, though there are some exceptions. HemMobile by Pfizer, and
Beat Bleeds by Baxter, help patients
to manage haemophilia. Bayer, the
maker of Clarityn, an antihistamine
drug, has a popular pollen-forecasting app. GSK, a drug firm with
various asthma treatments, offers
sufferers the MyAsthma app, to help
them manage their condition.
discuss their symptoms, problems

with other fellow patients. Mobile
health apps and devices are really making a strong impact in the
healthcare industry, as they may even
be able to diagnose disease and
prevent the likelihood of developing
dangerous medical conditions like
heart disease or diabetes.
Research has also proven that the
mobile health industry, along with
remote monitoring and telehealth
systems, has a wide impact on reducing hospitalizations and emergency
room visits throughout the healthcare
spectrum by improving communication and care coordination among
specialists, doctors, nurses, and
others. Nearly 92 percent of
emergency room visits are dropped
with the use of mobile health apps
and greater communication.
GSK, along with Propeller Health, is

developing custom sensors for GSKs
Ellipta asthma inhaler, so that the
pharma company can gather information on how patients use it. GSK
wants to know how well patients
comply with instructions on when
to take it, and to see how compliance relates to the safety, efficacy and
economic benefits of the drug.
Even drugmakers are

jumping into the m-health
bandwagon
A number of academic organizations

across Japan, including Saga, Tokyo, Jyuntendo and Mie University,
have recently incorporated mHealth
technologies into clinical trials, using
data generated from these devices to
assess such correlations as activity
level and pain relief, and the effectiveness of self-care among Type 2
Diabetes patients. mHealth is even
presenting the opportunity to help
reduce the suicide epidemic in Japan
(the nations seventh highest cause of
death) by providing real-time insight
into sleeping patterns of young adults
suffering from depression. Identifying outliers in this kind of objective
data can allow for faster intervention
and the ability to save lives.
M-health also has a role to play in

the billion dollar pharmaceutical industry. Smartphone apps can help
pharmaceutical companies with clinical trials of a proposed new drug to
measure disease progression more
accurately, and thus demonstrate
the efficacy of the treatment. After a
drug is approved these mobile apps
can be used to monitor their health
conditions. mHealth technologies
have the capability to collect powerful
data that can reveal what is and what
isnt working in a trial, providing
insight needed to make changes
early, saving time, money and
resources. leading life sciences
organizations in Asia are beginning
to recognize the potential new mobile
technologies have to help bring novel
and important medicines to patients
faster, safer, and more efficiently and
are embarking on the early stages of
exploring these devices in clinical
development.
34
BioSpectrum
| November 2016
Asian countries leading in

app development
Despite being late to the m-Health
race, Asian countries are not only
catching up but are also leading the
world in m-Health program implementations. Asia is also seeing a
record increase in m-Health applications and investments owing
|
to its maturing demographics and

widening access to mobile devices.
Nations in Southern Asia and Eastern
Asia and the Pacific, in particular, are
implementing the highest percent of
technology-enabled health programs,
according to data from the Center for
Health Market Innovations.
South Korea is one of the worlds
most technologically advanced and
digitally connected societies. Almost
80 percent of South Koreans have a
smartphone, and 97.7 percent of 18
to 24-year-olds do. South Korea is
already leveraging innovative technology to drive scientific discovery
and has the healthcare infrastructure
needed to hit the ground running
(for example, the Severance Hospital
in Seoul has a dedicated facility for
clinical trials, a large medical tourism practice and a robotic surgery
center). With South Koreas high
level of digital connectedness and its
rapid growth in the life sciences space
South Korea may soon be a driving
force in the adoption of mHealth
technology in drug development.
Singapore in particular has emerged
as a hotbed for mobile health devices,
with local doctors developing apps
such as ScolioTrack, which tracks the
progression of scoliosis. Connected
Health, a system of Bluetooth connected devices that compiles information into one convenient location,
has also emerged as a leading provider of mobile health technologies.
China too isnt lagging in this front.
Many Chinese tech companies are
launching m-Health-focused products that are revolutionizing the
way patients engage in and receive
healthcare services and information. For example, a company called
Haodf.com launched an iPhone app
in March 2011, which collects basic
information from hospitals and doctors (therapeutic specialty, rankings,
etc.) for users reference and allows
them to rate a doctors performance.
HealthcareApps
Additionally, the Spring Rain Doctor app claims to have 45,000 doctors online and can be connected to
patients for phone inquiries. This app
also provides advice and medical information in conjunction with Spring
Rains online information database.
Emerging economies such as Indonesia, Thailand and Malaysia are
also encouraging the development
of low-cost mobile technologies that
will give low-income individuals better access to the information and
advice they need when they are suffering from disease or poor health. The
World Health Organization (WHO)
says these low- and middle-income
governments are using information
and communication technology (ICT)
specifically to improve their health
programs. They do so because of six
major benefits: to extend geographic
access to health services, facilitate
patient communications, improve
diagnosis and treatment, improve
data management, streamline financial transactions, and mitigate fraud
abuse.
Highlighting that India is a hub for
m-health revolution, Stephen said,
Though many Asian countries are
leading the m-health revolution, India continues to be seen as a hub of
highly skilled developers that rapidly jump onto creative technology
approaches to the health problems
around them. The largest number of
firms that build health technology
apps, finding clients and customers
beyond their own country, is India.
But many other countries in Asia,
including Thailand, Vietnam, and
others, have a healthy ecosystem of
developer.
Money is in too!
The common thread running through
all apps is that they are affordable
and provide easy accessibility to
experts and consumers. For Asian
markets outside of Japan, these
attributes will continue to draw

funding, even though investors are
being more cautious than they were
in the last two years.
Dr Durand said, Its always

challenging to get fund for a startup, but we dont need wait to have
funds for start some development. In
healthcare we have now around 300
000 medical apps available on the
market. If we consider that 1 startup
in general built one app, it show that
funding an app is not a big issue. We
are more in a situation that we have
too many apps and concepts available in the market. Now its a bit too
late for launch an app. 97 percent of
these apps are not popular enough
but they still there and its generating
confusions.
Asian governments are fast recognizing the improved efficiency and

effectiveness of mHealth programs,
and are funding more of them each
year. This in part has convinced
corporations and entrepreneurs to
venture into the lucrative billiondollar industry. In Asia China clearly
leads the way in securing funding for
healthcare apps. App service operators raised around five billion yuan in
the first half of 2015 alone, according
to the Beijing-based Internet analysis firm iResearch, which pegged the
markets value that year at 4.3 billion
yuan and predicted a near-tripling
by 2017. Total fundraising in 2014,
the firm said, was some 4.6 billion
yuan. Chinas healthcare system also
suffers various setbacks as it has too
few doctors for its huge population.
Users, particularly in smaller towns,
are busy downloading apps that make
it easier for them to find good doctors, and book appointments. Huangzhou-based Guahao Technology
Co. makes two apps that do exactly
that, and are very popular. The company raised USD 394 million, the biggest
round for a healthcare startup in the
region last year. Healthcare startups in
China have raised the highest
cumulative funding in Asia.
Dr Durand also highlighted that a

huge gap exists among Asian countries when it comes to funding for new
innovation. Stating two examples,
Dr Durand explained, In Indonesia,
we dont have a telehealth initiative
supported by the government. No
money for this. But entrepreneurs
can try to built something linked to
the local government through the
smart city initiative or use a classi
Open government partnerships.
But Im sorry to tell that it is a long
process. However, In Singapore is
very easy to get direct support or
funding from the local government.
They have several programs some
supporting the initial investment (infrastructure ), others the promotion
and some specific clinical outcomes
( Home care, chronic diseases etc..).
One of the main program is through
the SPRING initiative. Thus we can
see the gaps exist between a strong
support for innovation in one country
like Singapore, while entrepreneurs
in Indonesia suffer due to lack of
much funding and support.
Institutional investors as well as

Internet giants such as Alibaba
Group, Tencent Holdings and Baidu
Inc. have been pouring money into
startups whose app services help
smartphone owners remotely consult doctors, schedule appointments
and pay hospital bills. Few apps that
have raised funding rounds above
USD 100 million include Lamabang,
made by Shenzhen Wangzhi Technology Co., which is an app for mothers.
Moms can share parenting tips, as
well as talk about food and fashion in
dedicated communities in the app.
Regulation
As these apps directly deal with
healthcare and well-being of the
users it is important that these apps
are regulated. Experts opine that
regulation for medical apps can be
split into two categories; those that
|
November 2016
BioSpectrum
35
HealthcareApps
general information but does not
provide personalised advice,
although it may be targeted to a
particular user group, is unlikely to
be considered a medical device
apps with software that is used
to book an appointment, request a
prescription or have a virtual consultation is also unlikely to be considered a medical device if it only has an
administrative function
trials, and the use of wearable

devices raise regulatory challenges as
sponsors question whether regulatory agencies in Asia and globally will
accept m-Health data.
are considered medical devices and

require regulation by the regulatory
authorities and those that are not. In
general any app that plays a role in
dose calculations, symptom tracking
or provides clinical guidance which
helps making a diagnosis or decision
in healthcare are likely to fall within
the scope of the medical devices directive. FDA cautions that a mobile
app which has not been sufficiently
validated can lead consumers to
undergo medical procedures they
might otherwise avoid, or avoid medical procedures they might otherwise
undergo. For example, a false positive
in the melanoma app might result
in a patient undergoing a needless
biopsy. A false negative result might
cause a patient to put off going to the
doctor to check the suspected
cancerous cells, delaying treatment.
Examples of medical apps

that need regulation
36
BioSpectrum
| November 2016
Examples of medical apps

which may not require
regulation:
Asia , in particular, faces seven key

challenges around mHealth, said
WHO in a regional workshop: lack
of mHealth policy, strategy and
legal framework to support the
national health system; uncoordinated
investment in ICT in health due to the
absence of an overarching plan for
eHealth; duplication of efforts due to
a low degree of cooperation, collaboration and sharing across sectors;
limited capacity within the public sector to implement eHealth programs;
widely differing levels of eHealth
maturity across and within countries; poor quality and disparities in
data with health information systems
existing in silos - segmented with
little interoperability and communication; and poor communication
infrastructure and lack of broadband
connectivity and internet access.
apps with software that provides
Saying that regulation is critical for
apps acting as accessories to medical

devices such as in the measurement
of temperature, heart rate, blood
pressure and blood sugars could be
a medical device as are programs
for prosthetics could be classed as
medical devices
apps with software that monitors
a patient and collects information
entered by the user, measured automatically by the app or collected by
a point of care device may qualify as
a medical device if the output affects
the treatment of an individual
While m-Health holds the promise of

new insights and research endpoints,
its use in the highly regulated, scientific environment of clinical trials
requires rigorous diligence and protections. Currently, there is no global
standard for m-Health in clinical
|
Stating the importance of regulation

Dr Durand mentioned, Yes regulation in medicine is a must. In many
countries the regulations are not at
the same levels but things are changing fast. We need to promote quality
and not quantity. When a bunch of
teenagers, or a genius IT guy built a
healthcare app its a good initiative
but we need to assist them. Regulations will help them to play safe with
the data they will collect. Standards
will drive interoperability and quality to ensure at the end physicians
can recommend these apps to their
patients.
HealthcareApps
medical apps, Stephen explained,It
is indeed necessary for governments
to always require that the sensitive
health data of individuals is kept
secure from theft or vandalism, and
kept private so that citizens dont
have their health information disclosed publically. Any health project
will salute and promote that necessity. That requirement does not need to
be a brake on the progress towards
adopting new technologies. Digital
health data, professionally managed,
can be guarded in terms of permissions, access, and security at the
same time as it advances new health
possibilities.
As we see new applications arise,
government agencies will hopefully
keep an open mind towards new
models of storing health data in the
cloud, while of course never compromising on the requirements of strong
safeguards of security and privacy.
Despite
challenges,
opportunities abound!
poorer countries for data to be

recorded onto mobile applications.
And paper recording, and its inefficiencies, will gradually recede.
Increasing
population,
rising
awareness of people for chronic
diseases, and continuous innovations
in technologies are few the major
driving factors for the Asia-Pacific
mobile health market. The growth
of mobile health services in this
region is also stimulating the demand
for connected devices. The overall
adoption of mHealth applications
can significantly increase availability
of information and engagement for
citizens in need of healthcare. With
the increasing penetration of smartphone devices, Asia is all set to lead
the world in this m-helath revolution.
Fortunately, the infrastructure needs

for mobile healthcare approaches
are not heavy. It is true that mobile
connectivity does not reach into
truly rural areas. But modern health
apps are still able to function while
out of range of a mobile signal, and
then simply sync the data up to the
network the next time the phone has
a signal. The more important issues
are meeting the moderate costs of devices, apps, and training, and ensuring the planning of projects to have
a full sense of ownership by local
institutions rather than by temporary
health projects.
Stephen concluded, I think it is inevitable that mobile healthcare will

go mainstream. It will not happen overnight, but in 10 or 20 years,
it will be increasingly normal in
November 2016
BioSpectrum
37
BioNews
IBM, Quest Diagnostics launch

Watson-powered genomic
sequencing service
IBM Watson Health and Quest Diagnostics has
announced the launch of IBM Watson Genomics from
Quest Diagnostics, a new service that helps advance precision medicine by combining cognitive computing with
genomic tumor sequencing. Memorial Sloan Kettering
Cancer Center (MSK) will supplement Watsons corpus
of scientific data with OncoKB, a precision oncology
knowledge base to help inform precision treatment
options for cancer patients.
The launch marks the first time that Watson for Genomics has been made widely available to patients and physicians across the country. Quest Diagnostics, a leader in
genomic sequencing and oncology diagnostics that serves
half the nations physicians and hospitals, extends these
advanced capabilities to thousands of the countrys community oncologists, who provide an estimated 70 percent
of cancer care in the United States. The Broad Institute
of MIT and Harvard will provide additional genome
sequencing capabilities as part of the collaboration.
The new service involves laboratory sequencing and
analysis of a tumors genomic makeup to help reveal
mutations that can be associated with targeted therapies
and clinical trials. Watson then compares those mutations against relevant medical literature, clinical studies,
pharmacopeia and carefully annotated rules created by
leading oncologists, including those from MSK. Watson
for Genomics ingests approximately 10,000 scientific
articles and 100 new clinical trials every month.
The beauty of Watson is that it can be used to dramatically scale access to knowledge and scientific insight,
whether a patient is being treated in an urban academic
medical center or a rural community clinic, said John
Kelly III, PhD, senior vice president, IBM Research and
Cognitive Solutions.
ma take medical experts weeks to prepare can now be

completed in significantly less time.
Precision medicine is changing the way we treat cancer
and giving new hope to people living with the disease,
said Jay G. Wohlgemuth, M.D., chief medical officer
and senior vice president of research, development and
medical, Quest Diagnostics.
However, access to genomic sequencing and tumor
analysis required to determine appropriate precision
medicine treatments for a patient can be a challenge. This
service combines Quests state-of-the-art tumor analysis and national access with the cognitive computing of
IBMs Watson and the deep cancer treatment expertise
of MSK. This is a powerful combination that we believe
it will leap frog conventional genomic services as a better
approach for identifying targeted oncology treatments.
Agilent unleashes its Intuvo 9000

a user friendly GC system
Agilent Technologies has added one more sword of state
in its arsenal. Recently, the company has divulged its new
Gas Chromatography (GC) system called Intuvo 9000
GC solution, offering users new innovative technology
that will help laboratories meet operational, scientific
and financial goals.
The company had conducted a global customer survey
before carving its new GC. The feedback it received during the survey was analyzed to make sure that its newly
designed machine overcome the challenges faced by
its customer in it earlier version. Former edition of GC
system had a major complain that it is very complex
and highly skilled operators are required to carry out its
operations.
Through this collaboration with the cancer communitys

leading clinical and pathology experts, thousands of more
patients can potentially benefit from the worlds growing
body of knowledge about this disease.
In Intuvo 9000, company has eliminated the aforementioned issue hence, making it an uncomplicated field to
play on. However, company claims that with Intuvo Flow
Technology Smart ID Keys, the Intuvo 9000 system
self-identifies installed components and self-configures
methods. Operations such as mid-column backflush are
made routine by eliminating complex setup and extra
calculators.
Bolstering the corpus of data Watson uses, MSK will

provide OncoKB, a database of clinical evidence that
will help Watson uncover treatment options that could
target the specific genetic abnormalities that are causing
the growth of the cancer. Comparison of literature that
Elaborating further on the GC, Eric Phillips, GC/MS Marketing Manager, Agilent Technologies, Wilmington, USA
said, We travelled to our global offices with questions
and then again revisited them with more question, the
entire exercise was conducted with a view of designing a
38
BioSpectrum
| November 2016
BioNews
device which is not only user friendly but also abolishes
all other road blocks of the process.
We began this innovative journey by listening carefully
to our customers around the world, stated Juan Aybar,
Agilent Business Manager, Chromatography and Mass
Spectrometry Business in EMEAI. The Agilent Intuvo
9000 GC system provides unprecedented ease-of-use
for the GC analyst, at the time lab managers/ owners
will experience an impressive boost in productivity and
financial outcomes that are now taken to level never seen
before in the GC market.
announces the launch of the Kleenpak Presto sterile

connector to be used in a wide range of applications in
upstream, downstream, and formulation and filling.
We launched the Presto genderless sterile connector family in direct response to customer demand for a
reliable, robust universal single-use fluid handling solution, said the companys President of Single Use Technologies, Mario Philips. With its intuitive operation and
easy to use features - we worked closely on this new generation design with our customers to ensure even greater
levels of sterility assurance.
Bharat Bhardwaj, Country Manager, Agilent Technologies opined, Agilent has been the market leader in GC
for the past 50 years. With this heritage, coupled with
an extensive network of industry partnerships and market experts, the brand was uniquely positioned to take
another leap forward by putting this transformational
technology in the hands of our customers.
The Kleenpak Presto sterile connector is a genderless

technology for the sterile connection of two fluid paths
even in uncontrolled environments. The connectors are
available in in., in., in. and in. hose barb sizes,
and with in. sanitary connections, and are made from
Bisphenol-A free polyethersulfone.
Kleenpak Presto sterile

connectors from Pall Life
The connectors can be used for a wide range of

applications and are 100% inspected at point of
manufacturer with device traceability and serialization
linked to this 100% quality control process.
Pall Life Sciences, a division of global filtration,

separation and purification leader Pall Corporation,
November 2016
BioSpectrum
39
BioNews
3Ms first tablet-based Mobile

Intraoral Scanner launched
Mobile tablets, commonplace in many aspects of clinical practice in health care settings, have arrived in the
dental industry with the introduction of the 3M Mobile
True Definition Scanner, a one-of-a-kind tablet-based
intraoral scanner that fits in your hand.
The compact, ergonomic design is similar to rechargeable tablets that patients and clinicians use in their daily
lives, allowing clinicians to move freely between operatories without power cords or carts. Flexible mounting options help to minimize workspace clutter, offering more
space for the clinician and assistant to maneuver in small
spaces. Informed discussion and visual patient communication is made easy with a system that can be placed
directly into the hands or lap of a patient, where they can
experience a cutting-edge digital visualization of their
oral anatomy, and ultimately, a better understanding of
proposed treatments. With easy setup - users can unbox
and scan in less than an hour - the 3M Mobile True Definition Scanner can seamlessly integrate into the practice.
The 3M Mobile True Definition Scanner takes the patient experience to another level, said Karen Burquest,
digital oral care global business director at 3M Oral Care.
This scanner offers clinicians the flexibility to place the
tablet in the patients hands so they can experience un40
BioSpectrum
| November 2016
precedented access, while the clinician educates them

about the treatment process. Because the tablet is compact and operates on battery, clinicians can easily hand
carry the scanner between operatories. This scanner will
impact the landscape of digital dentistry.
Developed with the tradition of 3M science in mind, this
new scanner is designed to deliver convenience for practitioners, as well as a memorable visual experience for the
patient. At 3M Oral Care, we are committed to inventing new products and processes that will positively impact a patients oral health for years to come, concluded
Burquest.
Restorations created from scans are proven to be accurate - and more consistently accurate - than other leading intraoral scanners, with a 99.7 percent fit rate.1 This
paired with the smallest wand on the market means scanning with this system is not only comfortable for clinician and patient alike, it delivers precision clinicians can
trust. With a low-price entry into digital impressioning
at just USD 16,995, this new mobile scanner fits the size,
mobility, practice requirements and budget needs of
practitioners.
Siemens Stride Coagulation

analyzer gets FDA clearance
Siemens Healthineers announced FDA 510(k) clearance for a hand-held portable coagulation analyzer. The
BioNews
Xprecia Stride Coagulation Analyzer delivers fast,
reliable Prothrombin Time International Normalized
Ratio (PT/INR) testing for point-of-care monitoring and
management of oral anticoagulation therapy with
warfarin, a vitamin K antagonist.
Millions of PT/INR tests are administered world-wide
each year as part of therapy monitoring for patients with
a host of conditions, including atrial fibrillation, heart
valve replacement surgery, deep vein thrombosis and
congenital heart defects, among others. The Xprecia
Stride Coagulation Analyzer was specifically designed to
meet the growing demand for fast and reliable PT/INR
results in physician offices and walk-in clinics to help
healthcare professionals make informed decisions about
patient care.
Winner of multiple international design awards such as
the Red Dot Award: Product Design for 2015 and the iFDesign Award, the analyzer includes a number of innovations and features not found on most other point-of-care
analyzers. No bigger than a smartphone and weighing
just 10.5 oz, the Xprecia Stride Coagulation Analyzer
can be held at virtually any angle and brought directly
to the patients finger for efficient and comfortable blood
sample application.
Among the many challenges of point of care testing,
accuracy and safety have become paramount to both
the user and patient. With the Xprecia Stride analyzer,
Siemens Healthineers delivers on the promise to bring a
safe and lab-accurate test directly to the patient, said Michael Sampson, Senior Vice President, Point of Care, Siemens Healthineers, North America. The Xprecia Stride
analyzer is designed to be safe, efficient and ergonomically friendly. By adding the Xprecia Stride analyzer to
our existing product portfolio in the U.S., we now have
the ability to cover the full range of hemostasis testing
from the hospital lab to the physicians office.
Todays busy healthcare professional is challenged by a
complex work environment and heavy patient workflow.
The Xprecia Stride analyzer was designed to address
these concerns through an intuitive user interface and
features such as an integrated barcode scanner to simplify data capture and improve patient workflow. To further enhance usability, the Xprecia Stride features simple
icons and animation in a color display more commonly
found in mobile devices than medical instruments.
The Xprecia Stride analyzer uses fresh capillary (fingerstick) whole blood and results are expressed as INR. It
utilizes the same Dade Innovin reagent used by Siemens Healthineers central lab analyzers to minimize any
potential for variability. Studies have shown the performance to be equivalent to a reference laboratory hemostasis system,1 with results available within minutes.
Safety features include a first-of-its kind test strip eject
button that allows the user to eject a used test strip
and easily dispose of it without touching it, minimizing
potential biohazard exposure.
When taken together, all of these innovations ultimately enable better patient care as point-of-care PT/
INR testing becomes critical to healthcare providers
managing the growing number of patients that require
anticoagulation therapy.
Thermo Fisher Scientific

recognized for sustainable labs
Technology company, Thermo Fisher Scientific has been
awarded a 2016 Go Beyond award for Thermo Scientific
TSX400 ultra-low temperature (ULT) freezer.
The Go Beyond awards recognize excellence in sustainability in laboratory and other high-technology facilities,
with nominations evaluated based on the impact of people, products and projects in the sustainable laboratory
community. Because of its ability to improve energy efficiency by up to 50 percent compared to ultra-low freezers that use conventional refrigerant, the TSX400 ULT
freezer has won this years award in the User Products
category. The award was presented to Thermo Fisher
on September 27 at the 2016 International Institute for
Sustainable Laboratories (I2SL) conference.
Academic researchers are increasingly aware of the energy efficiency benefits of ultra-low temperature freezers
due to the need to drive lower costs with a critical focus
on maintaining the quality and integrity of sample management. The Freezer Challenge tasks North American
laboratories to compete to become the most energy efficient, with up to eight awards across four categories for
university, government, pharmaceutical/biotech, and
clinical/hospital laboratories. The Challenge is an annual event conducted between January and May, with
the 2016 category winners announced on September
November 2016
BioSpectrum
41
BioNews
26 - day two of the I2SL conference. The conference is
comprised of technical presentations, symposia, discussions, workshops and exhibits to highlight and promote
advancements in laboratory efficiency and performance.
Our sponsorship of the North American Laboratory
Freezer Challenge reflects our commitment to supporting
the adoption of the best practices and technologies that
reduce a laboratorys energy expenditure, said Mr Chris
Champlin, vice president and general manager, Controlled Temperature Technologies, Thermo Fisher Scientific. Thermo Fisher is dedicated to promoting laboratory sustainability technologies that protect data integrity,
the laboratory footprint and our environment, something
that is reflected by our recent Go Beyond award for the
TSX400 ULT freezer.
Agilent, Burning Rock partner

on Molecular Diagnostics
Agilent Technologies Inc and Burning Rock have signed
an agreement under which Burning Rock will develop cancer diagnostics in China based on the Agilent
Sure Select target enrichment system.
Agilent is the leading provider of target enrichment for
next-generation DNA sequencing. Target enrichment
saves researchers time and resources by enabling them
to focus on regions of interest rather than looking at the
entire genome. Burning Rock is a fast-growing company
focused on developing cancer diagnostics based on DNA
sequencing.
As the leader in molecular cancer diagnosis in China,
Burning Rock is very pleased to partner with Agilent, a
global leader in diagnostics and genomics, said Yusheng
Han, the founder and chief executive officer of Burning
Rock. Collaboration between our two companies will
provide additional high-quality molecular diagnostic
solutions based on next-generation sequencing, including non-invasive testing, relapse monitoring, early-stage
diagnosis and cancer susceptibility. Fast and accurate
cancer diagnoses are becoming increasingly important in
China, with its extensive population and growing focus
on advancing human health.
We are excited to partner with Burning Rock to accelerate accurate diagnosis of cancer for patients in
China, said Jacob Thaysen, president of Agilents Diagnostics and Genomics Group. We believe that target
enrichment and next-generation sequencing have a vital role to play in personalizing medicine and ultimately
42
BioSpectrum
| November 2016
delivering treatments tailored to the individual. This is

especially so for complex diseases such as cancer.
Burning Rock plans to register its molecular diagnostic
kit with the China Food and Drug Administration. The
company believes the kit could become the first CFDAapproved capture sequencing-based cancer diagnostic
assay in the Chinese market.
GEs Bioprocessing Technology

and Training Center
Singapore: GE Healthcares Life Sciences business has
announced the opening of a GE Fast Trak Center in Songdo, Incheon Metropolitan City, South Korea. The new
USD 7.4 million Center will support the growth of South
Koreas rapidly expanding biopharmaceutical industry by
providing hands-on practical training, technology evaluation, manufacturing support, and consultancy services
in the latest strategies and technologies for upstream and
downstream bioprocessing.
Demand for GEs newest Fast Trak Center is expected to
be high. During the past five years the domestic production of biopharmaceuticals in South Korea has grown
nine percent, and exports grew almost 34 percent between 2014 and 2015, from USD 589 million to USD 809
million.
Kieran Murphy, President and CEO of GE Healthcares
Life Sciences business, said: Were delighted to be
investing in South Korea with our fifth global Fast Trak
Center, which brings us closer to our customers in one
of the worlds key bioprocessing hubs, enabling us to
share our global knowledge and expertise at a local level. South Korea has some of the worlds most innovative
biopharma companies, and we look forward to further
supporting the growth of the industry here.
The 2,200 m2 APAC Fast Trak Center in Songdo, South
Korea adds to GEs existing global network of Fast Trak
Centers in the USA, Sweden, India, and China. The company also has satellite Fast Trak Centers in Turkey, Japan
and Singapore. Worldwide, around 500 customers attend standard Fast Trak courses every year, with training
available in local languages. In addition, there are customized courses that are built upon request and tailored
according to customer needs. GEs Fast Trak Training
Centers are specifically designed to help biopharmaceutical manufacturers increase their process productivity,
reduce cost and enable them to bring their product to
market faster.
BioNews
November 2016
BioSpectrum
43
BioNews
Clinigen makes foray into Japan
The opening of the Japanese office further expands its

international supply chain and operational network.
Further building on its presence in the Asian region,

Burton-based Clinigen Group,has launched its Japanese
business with the opening of an office in Tokyo, Japan.
Alongside the launch, Clinigen K.K. will transfer the Marketing Authorisation for its lead Specialty Pharmaceutical (SP) product Foscavir (foscarnet sodium) back from
Nobel Pharma on 1 November 2016. Nobel Pharma has
been the distribution partner for Foscavir in Japan since
2011.
Teva to buy Koreas Celltrion?
Japan is the second largest pharmaceutical market globally and opening an office in Japan provides Clinigen with
immense opportunities. The Japanese business will allow
the Group to supply and distribute both licensed and unlicensed medicines in the country, providing additional
infrastructure to support Clinigens mission to deliver the
right medicine to the right patient at the right time.
Clinigen already has a presence in Asia with the acquisition of Link Healthcare in 2015. The Japanese business
will be known as Clinigen KK. Foscavir is indicated to
treat cytomegalovirus (CMV) retinitis in patients with
acquired immunodeficiency syndrome (AIDS) or Cytomegalovirus viremia and cytomegalovirus disease in hematopoietic stem cell transplant (HSCT) patients. Japan
was the first market where Clinigen successfully achieved
a new license extension for HSCT patients in 2011.
With more than 2000 patients treated annually, Japan
remains an important market for Foscavir. Clinigen will
assume full marketing and distribution responsibility
for Foscavir from November, to supply the product to
healthcare professionals and patients across Japan.
Mr Shaun Chilton, chief executive designate of Clinigen,
said, We are focused on building our market leadership positions by expanding in key geographic regions to
drive sustained organic growth and better address unmet
patient needs for access to critical medicines.
The opening of our Japanese business helps support our
goals and will enable us to effectively serve the Japanese
market by supplying our own products, beginning with
Foscavir.
At a time when many pharmaceutical and biotechnology
companies are looking for specialist partners to work with
them in Asia, the opening of our Japanese office gives us
more opportunities to provide customers with our global expertise combined with local knowledge.Clinigen
employs over 500 people globally, across 11 locations.
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BioSpectrum
| November 2016
With a view to strengthen its biosimilars portfolio,

Isreali drug giant Teva pharmaceuticals said that it may
consider acquiring Korean biosimilar giant Celltrion .
We will continue to investigate such opportunities as we
balance risk and seek complementary skills in our partners, Mr Yonatan Beker, director of corporate reputation at Teva, told The Investor via email on Oct. 14.
Mr Beker said that biosimilars are a key element of Tevas
overall strategy going forward and the company is committed to strengthening its biosimilar portfolio, both organically, as well as through partnership and selective
investments. With the Celltrion partnership, we will
expand into the upcoming wave of biosimilars of drugs
whose original patent expires between 2015 and 2020,
he said.
Teva was one of the potential bidders along with other
global peers including Roche and AstraZeneca to acquire
Celltrion in 2014 when the Korean firm was put on sale.
With fruitful income from its blockbuster drug Remisma,
Celltrion scrapped plans to sell the firm.
Recently Teva inked a pact with the Korean giant seeking exclusive rights to commercialize the Korean firms
CT-P10, a potential biosimilar for Roche and Biogens
Rituxan, and CT-P6, a copycat of Roches breast cancer
drug Herceptin, in Canada and the US. The deal will help
Teva establish a larger footprint in the biosimilar space.
Teva CEO Mr Erez Vigodman in particular has highlighted biosimilars as a key component of the Israeli
drugmakers strategy. But the company has already struck
out once in the field: In 2013, one-time biosim partner
Lonza backed out of the pairs 2009 agreement after
development and marketing costs piled up.
DHL invests SGD 140mn

in Singapore
DHL Express has launched S$140 million (85 million)
DHL South Asia Hub, a 24-hour express hub facility located within Changi Airfreight Centre (CAC) at Singapore
Changi Airport. The 23,600 sqm facility is outfitted with
fully automated express parcel sorting and processing
BioNews
system and is set to boost its operational capacity and
efficiency, offering speedier deliveries for customers.
The new facility is 33 percent larger than the previous
hub. Coupled with the enhanced operational efficiency,
the new hub provides DHL with additional capacity.
Besides allowing it to handle the growing shipment volumes, some export shipments can now be sent directly to
the hub, bypassing the service center. This streamlines its
overall operations by reducing travel and shipment handling time. With the hub located within the CAC, a 24hour Free Trade Zone managed by Changi Airport Group
(CAG), it also improves the flow of goods between aircraft
and the facility and allows consignments to be shipped or
transshipped within an hour.
Ken Allen, CEO, DHL Express, said, Over the years,
weve invested significantly to bolster our network and
services in Asia Pacific. Our investment in the DHL South
Asia Hub is the most recent in a series of global network
investments made, and is the largest infrastructural investment made in Singapore to date. The countrys strategic location not only boosts our operational network capabilities, but also supports growing trade in the region
aided by a stronger global economy.
Ken Lee, CEO, DHL Express Asia Pacific, said, The DHL
South Asia Hub is a significant milestone in further enhancing our multi-hub strategy in the region. With four
hubs in Asia Pacific, Hong Kong, Shanghai, Singapore
and Bangkok, this links over 70 DHL Express Gateways
located throughout the region. Together, these facilities
reinforce our customer commitment to provide the most
efficient international express connectivity between key
markets in the region. This will also allow us to add more
network flights in and out of Singapore, such as the recent introduction of the Phnom Penh-Bangkok flight
that adds to our existing Bangkok-Singapore service, as
regional trade continues to grow.
The hub allows us to meet customer needs more effectively in this age of an on-demand economy. With our fully automated system, the facility processes up to 24,000
shipments and documents per hour and can handle over
628 tonnes of cargo during the peak processing window,
tripling our cargo handling capacity and processes shipments six times faster as compared the manual operations in the previous hub. The increased efficiency allows
us to look into streamlining our service center operations in Singapore from end to end, giving our customers even faster deliveries and better business efficiency,
said Frank-Uwe Ungerer, Senior Vice President and
Managing Director, DHL Express Singapore.
Hanmi pharmaceuticals
in troubled waters!
New blockbuster cancer drug from South Koreas Hanmi
pharmaceuticals is in troubled waters after a patient died
of a severe skin-related side effect linked to the drugs use.
Hanmis lung cancer drug Olmutinib, also known as
HM61713 or BI148294, is a third-generation lung cancer
therapy for patients who have developed a tolerance to
existing lung cancer treatments.
Further to add to the woes, Hanmis licensing partner
Boehringer Ingelheim announced that it would return the
drugs development and commercialization rights it had
purchased from the Korean drugmaker in July 2015 in a
deal valued at USD 730 million.
As per the Korean Herald, the Korean Ministry of Food
and Drug Safety has prohibited doctors from prescribing
Olmutinib to new patients and warned patients already
using Olmutinib to use the drug with caution in consultation with doctors, citing three cases of life-threatening
side effects linked to the drugs use during clinical trials.
The ministry officials will meet up to decide on the causal
relationship between the drug and the given side effects
to determine its next moves, which could include completely banning the drugs sales, Yonhap News Agency
reported.
Conditionally approved for sale under the name Olita
Tab, Olmutinib had just completed first and second
phase trials held locally. The firm is mandated to submit
the results of the drugs third phase trials at a later date.
At the same time, the German pharma giant had been
carrying out second phase clinical trials in Europe, with
plans to begin second stage trials in the US where the
drug was designated a breakthrough therapy by the US
Food and Drug Administration.
However, Boehringer Ingelheim announced Friday that
it is terminating its licensing deal with Hanmi based on
November 2016
BioSpectrum
45
BioNews
a re-evaluation of all available clinical data on Olmutinib
and recent treatment advances made in the treatment of
EGFR mutation-positive lung cancer.
Of the 730 patients treated with Olmutinib, two patients
showed symptoms of toxic epidermal necrolysis, while
another patient was diagnosed with Stevens-Johnson
syndrome.
Among the two patients diagnosed with TEN, one died
due to the skin condition caused by using the drug, while
another recovered. The patient diagnosed with SJS died
due to the progression of the patients lung cancer.
During an emergency press conference, Hanmi Pharmaceutical CEO Mr Lee Gwan-sun said the company is examining multiple ways as to how it will continue on with
the development of Olmutinib, vowing to set a direction
in the near future. For the time being, the Korean drugmaker plans to conclude the ongoing second phase trials
taking place in Europe on behalf of Boehringer Ingelheim
by the end of next month, as scheduled.
Global pharma giant AstraZeneca has been making headway in developing a similar targeted lung cancer treatment known as Tagrisso (AZD9291). The firm submitted
the results of its third-phase clinical trials to the US Food
and Drug Administration in July.
In the case that Tagrisso is approved before Olmutinib
-- which now appears highly likely -- Boehringer Ingelheim would have a hard time finding patients for Olmutinib, a drug meant for use by patients with no alternative
treatment options, Hanmi Vice President Mr Son
Ji-woong said to the news agency.
Meanwhile, South Koreas financial authorities said
that they will investigate into Hanmi Pharmaceutical as
to whether the companys announcement of a breakup
with German drug giant Boehringer Ingelheim on a lung
cancer treatment last week was delayed intentionally for
alleged insider trading, officials said Monday.
Since it is a significant case causing immense losses to
investors, we will look into possible insider trading, Nam
Chan-woo, an official at Korea Exchange, told The Korea
Herald. The investigation might take days, but we will
come up with a result as soon as possible.
India urges Japan to provide

wider pharma market access
46
BioSpectrum
| November 2016
The Indian commerce Minister, Nirmala Sitharaman has

urged Japan to provide Indian pharmaceutical sector
with a wider share and greater market access in Japan.
Sitharaman further pointed out that the share of India in
the Japanese drug market continued to be below par and
limited mostly to active pharmaceutical ingredients (or
APIs - raw materials for drugs). She said the demand for
generic medicines in Japan and Indias capability to meet
this demand can prove a win-win for both countries.
An official statement by Sitharaman read, The Japanese
pharmaceutical market offers a huge untapped potential
for Indian pharma industry. Indias strength in pharma
sector is well established. This, coupled with the decision
of Government of Japan towards attaining an 80 per cent
share of generic medicines by 2018, should provide an
opportunity for the generic drug industry of India, She
further said that Indian companies should use the IndiaJapan Comprehensive Economic Partnership Agreement
(CEPA) much more to boost exports to Japan, she said at
a seminar organised by think-tank RIS.
The minister expressed concern over Indias trade deficit with Japan increasing from USD 3.1 billion before the
CEPA was inked in 2011 to USD 5.2 billion thereafter. She
said there was a need to address implementation issues of
CEPA. For example, she said, Japan had accorded preferential tariff to fish surimi from India. A negligible amount
of an imported cryo-protectant, TSPP, is applied for preservation. Though the value of the TSPP is less than 0.5
per cent of the overall product cost, it is precluded from
CEPA benefits as the product is not of Indian origin, she
pointed out.
Japan and India are the second and third largest economies in Asia. The economic engagement witnessed significant rise after both countries signed a Comprehensive
Economic Partnership Agreement (CEPA) in 2011.
The trade between the two countries pre-CEPA in 2010
was USD 10.4 billion and currently it stands at USD 14.5
billion. Trade deficit with respect to Japan was USD 3.1
billion pre-CEPA, and now it is USD 5.2 billion.
India requests Green Channel

for export of drugs to China
With a view to bridge the increasing trade gap between
the two countries, Chinese vice Minister of finance and
commerce Mr Wang Shouwen said that the country will
act on the concerns expressed by India and give greater market access to domestic products. The Chinese
BioNews
minister is here to attend the sixth BRICS Trade
Ministers meeting.
In recent meeting held in Indias national capital, Delhi,
Nirmala Sitharaman raised concerns over the widening
trade deficit between the two countries. Both the leaders
exchanged notes on trade and commerce and agreed that
the mounting bilateral trade deficit has been a cause for
concern for India which seeks greater market access for
its goods for a long-term sustainable trade relationship,
explained the officials.
Indias exports to China were at USD 9 billion in 201516, imports were USD 61.7 billion, leaving a trade gap of
USD 52.7 billion. Ms Sitharaman requested expeditious
clearances for import of Indian rice besides a Green
Channel for import of Indian pharmaceutical products
to China - especially those which already have US FDA
and EU FDA accreditation.
Ms Sitaraman also mentioned that the long drawn procedures for clearances tend to frustrate the Indian companies seeking business opportunities in China and hence
she urged the country to speed up its approval and clearance processes. The Chinese Minister said that recently
China has quickened the pace of granting clearances
to Indian pharma companies for import of the pharma
products.
identified APOE as a major, widely confirmed susceptibility gene in common late-onset Alzheimers disease.
Translation of these findings to metabolic-pathway
analyses and drug discovery and development continued in GSK, leading to Phase III trials now under way
to evaluate the drug rosiglitazone for the treatment of
Alzheimers disease.
Dr. Roses served as Jefferson-Pilot Professor of Neurobiology at Duke University and held several senior positions. Prior to joining Duke, he had a long career with
GlaxoSmithKline (GSK).
He founded his own company, Zinfandel Pharmaceuticals, to conduct clinical trial of his research for prevention
of Alzheimers Disease. The company used pharmacogenetics to improve prediction of risk for Alzheimers disease and facilitate the development of effective therapies.
She also requested the Chinese vice-minister to consider

demonstration IT/ITeS projects for Indian companies,
which have acquired global acclaim, an official statement
issued after the meeting said.
Dr. Roses was distinguished as a scientist who challenged

the prevailing theories of Alzheimers Diseases and
brought new perspectives of understanding the cause of
the disease.
The Chinese vice minister also sought cooperation of India on various multilateral fora where China and India
are engaged and assured that Indias concerns on a Single undertaking will be duly taken on board with services
being an integral part of the cooperation agreement.
Dr. Roses was a member of the Science Board of the US

Food and Drug Administration between 2003-2007. He
was a member of the Boards Subcommittee on Science
and Technology that in 2007 authored the report FDA
Science and Mission at Risk.
Renowned neurologist, Allen

Roses, passes away
80% of data in Chinese clinical

trials have been fabricated
Allen David Roses, a renowned neurologist who pioneered breakthrough research in Alzhiemers Disease,
passed away on Sept 30, 2016.
A recent investigation led by the Chinese State Food and

Drug Administration (SFDA) revealed that nearly 80
percent of the data used in clinical trials of new pharmaceutical drugs have been fabricated. The investigation looked at data from 1,622 clinical trials for new
pharmaceutical drugs currently awaiting approval.
He was one of the first clinical neurologists to apply molecular genetic strategies to neurological diseases. His
laboratory reported the chromosomal location for more
than 15 diseases, including several muscular dystrophies
and Lou Gehrigs disease. He led the team that in 1992
With these fraudulent activities coming to light nearly 80

percent of current drug applications, which were await-
November 2016
BioSpectrum
47
BioNews
BioNews
ing approval for mass production, have now been cancelled. The SFDA found that the more than 80 percent
of the data failed to meet analysis requirements, were
incomplete, or totally non-existent.
The report also mentioned that many of the new drugs
awaiting approval were actually a combination of existing
drugs, they also showed that many clinical trial outcomes
were written before the trials had actually taken place,
and the data had been simply manipulated to match what
companies wanted to find.
With all these findings, Chinese pharmaceutical industry
is in a big trouble and the SFDA has to now worry about
the drugs that were marked safe and approved. Experts
said that industries donot adhere to the guidelines and
follow the regulation.
The SFDA report was released by the state-owned Economic Information Daily Newspaper, and, as yet, theres
no English version available online to go over with a finetoothed comb, so for now, were taking the Chinese medias word for it. But as shocking as it all sounds, Economic Information Daily Newspaper also cites unnamed
industry insiders who werent surprised in the slightest at
the revelations.
Koreas Hanmi inks deal with

Roches Genetech
South Koreas Hanmi Pharmaceutical has inked a deal
with Roches Genentech (to develop and commercialize
Hanmis pan-RAF inhibitor, Phase 1-stage HM95573.
HM95573 is a pan-RAF inhibitor currently in Phase I
clinical development. The Phase I trial is being underwritten by the South Korean Ministry of Health and Welfare
for USD 545,843 US. RAF kinases have three subtypes,
A, B and C, and are associated with several different
types of cancers. RAF stands for rapidly accelerated fibrosarcoma, and they are retroviral oncogenes that are
overexpressed in cancer.
Under the terms of the deal, Hanmi will receive an upfront payment of USD 80 million, milestones up to
USD 830 million and tiered double-digit royalties on net
sales. We are pleased to collaborate with Genentech,
which has significant expertise in the field of oncology,
said Gwan Sun Lee, Hanmis chief executive officer and
president, in a statement. We are excited about the potential this license agreement with Genentech will bring
to the development of HM95573 and the potential benefit
this may offer to cancer patients worldwide.
48
BioSpectrum
| November 2016
Speaking about the deal, James Sabry, senior vice president and global head of Genentech Partnering said in a
statement, This collaboration demonstrates our commitment to bring the best science in the world to Genentech with the ultimate goal of developing life-changing
therapies for people with cancer. We are excited to partner with Hanmi and leverage their scientific insights to
develop novel therapies that target the MAPK pathway.
With 28 research projects underway Hanmi is clearly focusing on building a robust product pipeline. The companys main areas of focus are on on novel long-acting biologics based on its Lapscovery platform and combination
therapies in diabetes and obesity and on targeted agents
against cancer and autoimmune disorders.
The company has had a string of licensing deals valued at
USD 6.42 million recently. Son Jee-woong, the companys chief medical officer, said, Nearly 15 percent of the
companys total sales revenue is reinvested in the companys research and development for the past 15 years.
Such a ratio is unseen in any other pharmaceutical company in the world. Despite last years immense success,
the company is still quite small compared to other global
drug companies. In order to compete in the global market, Hanmi should further develop core technologies in
specialized categories.
Hanmi has also signed pacts with Johnson & Johnson
(JNJ)s Janssen Pharmaceuticals to develop and commercialize oxyntomodulin-based drugs that improve
metabolism, insulin secretion and suppress appetite. Under that deal, Janssen has global rights to develop and
commercialize HM12525A except in Korea and China.
J&J paid an upfront fee of USD 105 million, and Hanmi
could receive up to USD 810 million in various milestone
payments, as well as tiered double-digit royalties.
AbbVie launches API

facility in Singapore
Global biopharmaceutical company AbbVie has launched
small molecule active pharmaceutical ingredient (API)
manufacturing facility in Singapore.
The new 120,000 square-meter site, located in the Tuas
Biomedical Park, is AbbVies first manufacturing facility
in Asia and will also include a biologics manufacturing
facility that is expected to be fully operational by the end
of 2018.
Combined, the API and biologics facilities represent a
BioNews
BIOTRONIK plans to invest

SGD30 mn in Singapore
USD320 million (SGD400 million) investment in Singapore that will employ more than 250 new employees, the
majority of whom will be hired locally in Singapore, including skilled positions across manufacturing, technical
operations, administration, quality, information technology and supply chain.
Our goal as AbbVie is to assure patients around the
world have access to new and innovative medicines
when they need them and where they need them, said
Dr Azita Saleki-Gerhardt, senior vice president, operations, AbbVie. Today, with the opening of the first phase
of our Singapore facility, we will further strengthen our
manufacturing capabilities and continue to enhance our
support of AbbVies pipeline in the therapeutic areas of
oncology and womens health for patients around the
world.
Speaking at the opening ceremony, Site Director Dr
Marc ODonoghue, added, Singapore is recognized as a
leader in the biopharmaceutical industry and AbbVie is
excited to open its facility and begin operations. Singapore has a robust infrastructure, a highly educated and
skilled workforce and provides a supportive environment
for manufacturing. Our presence in Singapore establishes AbbVies footprint in Asia and provides geographic
balance in AbbVies manufacturing network to ensure
continuity of supply.
AbbVies choice of Singapore for its first in Asia manufacturing facility is testament to our capabilities as a
high-quality, global biopharmaceutical manufacturing
hub. Given our track record of providing a world-class
business environment and skilled talent pool to companies, we enable companies such as AbbVie to develop
and manufacture innovative products to deliver value
for patients worldwide, said Ms. Weng Si Ho, director,
biomedical sciences, Singapore Economic Development
Board (EDB). EDB will continue to commit strong investments in talent, infrastructure and technology to support the strong growth in the biopharmaceutical industry.
AbbVies manufacturing network now includes 13 locations across the United States, Europe, Asia and Puerto
Rico, as well as strategic partnerships with third-party
manufacturers.
Germany based developer of cardio and endovascular

medical technology, BIOTRONIK, has launched a new
manufacturing facility in Singapore to manufacture
hybrid drug-eluting coronary stent and pacemaker.
The new site includes a 1500 m ISO class 7 cleanroom, supplying the global market with products for the
companys vascular intervention and cardiac rhythm
management businesses. The facility will develop Orsiro,
a hybrid drug-eluting coronary stent, along with Solia
pacemaker leads.
Singapores skilled workforce, excellent infrastructure
and favorable business environment made it a natural
choice for BIOTRONIK as we seek to expand our global
footprint, said Erik Trip, Managing Director, Asia Pacific
Manufacturing, BIOTRONIK.
We are building a professional team at the new site and
will eventually create hundreds of new jobs in this exciting industry. This investment will support BIOTRONIKs
dynamic growth, both in the Asia Pacific region and
globally.
The company plans to create over 200 jobs for highlytrained operators and professionals in R&D and senior
leadership roles, investing more than SGD 30 million
into operations in the country over the next few years.
We welcome BIOTRONIKs decision to establish its Asia
Pacific manufacturing facility in Singapore. This is testament to our strong manufacturing workforce, high quality
standards, and deep science and engineering capabilities,
which are important in the production of implantable
cardiovascular devices, said Weng Si Ho, Director,
Biomedical Sciences, Singapore Economic Development
Board (EDB). Asia continues to provide an exciting
growth opportunity for global medical device companies.
We are confident that Singapore will continue to grow
as a global medical technology hub, which will enable
further economic growth and good jobs created here.
Besides Singapore, BIOTRONIK has manufacturing hubs
in US, Germany and Switzerland to develop implantable
pacemakers, defibrillators and stent therapy.
November 2016
BioSpectrum
49
BioNews
Kingshuk at kingshuk.sircar@mmactiv.in
50
BioSpectrum
| November 2016
BioNews
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BioSpectrum
| November 2016

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Senior VP, Clinical Risk and Data

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ASEAN nations share common vision

global best practices. Technically, the regulator has been

India has today emerged as the fastest growing

Three years ago DBT had said that diagnostics

Critics from the industry feel that the

The Department of Biotechnology has promoted this

Regulation is an important component contributing

The medical devices and diagnostics sector is one

As mentioned above, the Make in India policy has

Are you satisfied with the outcome on

The effort made by the government to promote

I am confident that we will see more industry-academia

There is no deadlock on biotech crops. There are

the supervision of the regulatory framework. These crops

On the GM crops issue, things are stuck due

India has been the pioneer in notifying rules

In the last two years, there have been many reforms in

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Make in India campaign has pitched India as a

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Biodesign programme is one of the examples of

rapid, indigenous, low cost medical devices and implants

How are you planning to use nanotechnology

Nanotechnology has major advantages for both

You have announced research scholarships

For the biotechnology sector, partnership with